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Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Mini-Review Article

Application of Analytical Tools and Techniques for Estimation of a Proton Pump Inhibitor (Esomeprazole Magnesium Trihydrate): A Comprehensive Review

Author(s): Sanat Kumar Dash, Sasmita Kumari Acharjya*, Atyurmila Chakraborty, Mitali Sahoo, Satyanarayan Tripathy, Bimala Tripathy and Ramanath Deo

Volume 18, Issue 7, 2022

Published on: 24 June, 2022

Page: [677 - 693] Pages: 17

DOI: 10.2174/1573412918666220426110831

Price: $65

Abstract

The application of various sophisticated analytical tools and techniques is essential for estimating an active pharmaceutical ingredient present in either biofluids or pharmaceutical dosage forms. Reporting the multiple analytical methods used to quantify esomeprazole magnesium trihydrate, a proton pump inhibitor, is the ultimate goal of this review article.

This article deals with a detailed discussion of different reported analytical procedures along with their pros and cons and their relevant criteria for quantifying the drug. Various analytical techniques like UV-Visible spectrophotometry, HPLC, HPTLC, hyphenated techniques, etc., are developed to assess the esomeprazole magnesium trihydrate in bulk materials, different pharmaceutical formulations, and biological matrices.

Literature survey confirmed that the hyphenated techniques and chromatographic techniques are the best tools for biological matrices. Spectroscopic methods like UV and visible techniques are widely used for pharmaceutical matrices. All of the reported methods are accurate, precise, costeffective, and sensitive.

Keywords: Esomeprazole magnesium, pharmaceutical formulation, proton pump inhibitor, review, hyphenated techniques, HPLC.

Graphical Abstract
[1]
Haque, S.K.; Ratemi, E.S. Drug development and analysis review. Pharm. Chem. J., 2017, 50(12), 775-778.
[http://dx.doi.org/10.1007/s11094-017-1543-1]
[2]
Patel, K.N.; Patel, J.K.; Patel, M.P.; Rajput, G.C.; Patel, H.A. Introduction to hyphenated techniques and their applications in pharmacy. Pharm. Methods, 2010, 1(1), 2-13.
[http://dx.doi.org/10.4103/2229-4708.72222] [PMID: 23781411]
[3]
Sharma, S.; Goyal, S.; Chauhan, K. A review on analytical method development and validation. Int. J. App. Pharm., 2018, 10(6), 8-15.
[http://dx.doi.org/10.22159/ijap.2018v10i6.28279]
[4]
Kalaitzakis, E.; Björnsson, E. A review of esomeprazole in the treatment of Gastroesophageal Reflux Disease (GERD). Ther. Clin. Risk Manag., 2007, 3(4), 653-663.
[PMID: 18472988]
[5]
Hatlebakk, J.G. Review article: Gastric acidity-comparison of esomeprazole with other proton pump inhibitors. Aliment. Pharmacol. Ther., 2003, 17(1)(Suppl. 1), 10-15.
[http://dx.doi.org/10.1046/j.1365-2036.17.s1.3.x] [PMID: 12614300]
[6]
Kendall, M.J. Esomeprazole-the first proton pump inhibitor to be developed as an isomer. Aliment. Pharmacol. Ther., 2003, 17(1), 1-4.
[http://dx.doi.org/10.1046/j.1365-2036.17.s1.1.x] [PMID: 12492728]
[7]
Hellström, P.M.; Vitols, S. The choice of proton pump inhibitor: Does it matter? Basic Clin. Pharmacol. Toxicol., 2004, 94(3), 106-111.
[http://dx.doi.org/10.1111/j.1742-7843.2004.pto940302.x] [PMID: 15049339]
[8]
Andersson, T.; Hassan-Alin, M.; Hasselgren, G.; Röhss, K.; Weidolf, L. Pharmacokinetic studies with esomeprazole, the (S)-isomer of omeprazole. Clin. Pharmacokinet., 2001, 40(6), 411-426.
[http://dx.doi.org/10.2165/00003088-200140060-00003] [PMID: 11475467]
[9]
Esomeprazole magnesium trihydrate. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Esomeprazole-magnesium-trihydrate
[10]
Nataraj, K.S.; Tejaswini, M.S.D.; Chaitanya, K.; Sayeed, N.; Roshna, N.; Manasa, I. Stability indicating method validation for the estimation of esomeprazole magnesium capsules and determination of potential impurities by RP-HPLC. Int. J. Drug Dev. & Res, 2013, 5(4), 273-279.
[11]
Al-salloum, I.; Al-sabti, B. Stability study of esomeprazole preparations in different packaging material using stability indicating validated HPLC method. World J. Pharm. Pharm. Sci., 2019, 8(9), 20-25.
[13]
Shaik, N.B.; Rani, G.P.; Kukati, L.; Kanagala, P. Formulation and evaluation of press coated tablets of esomeprazole. World J. Pharm. Res., 2018, 7(9), 1711-1741.
[14]
McKeage, K.; Blick, S.K.A.; Croxtall, J.D.; Lyseng-Williamson, K.A.; Keating, G.M. Esomeprazole: A review of its use in the management of gastric acid-related diseases in adults. Drugs, 2008, 68(11), 1571-1607.
[http://dx.doi.org/10.2165/00003495-200868110-00009] [PMID: 18627213]
[15]
Brunton, L.; Chabner, B.A.; Knollman, B. Goodman and Gillman: The Pharmacological Basis of Therapeutics, 12th ed; McGraw-Hill: New York, 2010.
[16]
Nexium@ (esomeprazole magnesium). Delayed-Release Capsules. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021153s022lbl.pdf
[17]
Baker, D.E. Intravenous proton pump inhibitors. Rev. Gastroenterol. Disord., 2006, 6(1), 22-34.
[PMID: 16520709]
[18]
Fock, K.M.; Ang, T.L.; Bee, L.C.; Lee, E.J. Proton pump inhibitors: Do differences in pharmacokinetics translate into differences in clinical outcomes? Clin. Pharmacokinet., 2008, 47(1), 1-6.
[http://dx.doi.org/10.2165/00003088-200847010-00001] [PMID: 18076214]
[19]
Johnson, T.J.; Hedge, D.D. Esomeprazole: A clinical review. Am. J. Health Syst. Pharm., 2002, 59(14), 1333-1339.
[http://dx.doi.org/10.1093/ajhp/59.14.1333] [PMID: 12132559]
[20]
Sugimoto, M.; Jang, J.S.; Yoshizawa, Y.; Osawa, S.; Sugimoto, K.; Sato, Y.; Furuta, T. Proton pump inhibitor therapy before and after endoscopic submucosal dissection: A review. Diagn. Ther. Endosc., 2012, 2012, 791873.
[http://dx.doi.org/10.1155/2012/791873] [PMID: 22851882]
[22]
Esomeprazole Magnesium. Available from: https://www.rxlist.com/esomeprazole-magnesium-drug.htm#dosage
[24]
Wedemeyer, R.S.; Blume, H. Pharmacokinetic drug interaction profiles of proton pump inhibitors: an update. Drug Saf., 2014, 37(4), 201-211.
[http://dx.doi.org/10.1007/s40264-014-0144-0] [PMID: 24550106]
[25]
Humphries, T.J. Clinical implications of drug interactions with the cytochrome P-450 enzyme system associated with omeprazole. Dig. Dis. Sci., 1991, 36(12), 1665-1669.
[http://dx.doi.org/10.1007/BF01296606] [PMID: 1748033]
[26]
Drug Interactions between itraconazole and Nexium. Available from: https://www.drugs.com/drug-interactions/itraconazole-with-nexium-1406-0-1015-567.html
[27]
Hassan-Alin, M.; Andersson, T.; Niazi, M.; Liljeblad, M.; Persson, B.A.; Röhss, K. Studies on drug interactions between esomeprazole, amoxicillin and clarithromycin in healthy subjects. Int. J. Clin. Pharmacol. Ther., 2006, 44(3), 119-127.
[http://dx.doi.org/10.5414/CPP44119] [PMID: 16550734]
[28]
Kahrilas, P.J.; Falk, G.W.; Johnson, D.A.; Schmitt, C.; Collins, D.W.; Whipple, J.; D’Amico, D.; Hamelin, B.; Joelsson, B. The esomeprazole study investigators. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: A randomized controlled trial. Aliment. Pharmacol. Ther., 2000, 14(10), 1249-1258.
[http://dx.doi.org/10.1046/j.1365-2036.2000.00856.x] [PMID: 11012468]
[29]
Johnson, D.A.; Benjamin, S.B.; Vakil, N.B.; Goldstein, J.L.; Lamet, M.; Whipple, J.; Damico, D.; Hamelin, B. Esomeprazole once daily for 6 months is effective therapy for maintaining healed erosive esophagitis and for controlling gastroesophageal reflux disease symptoms: A randomized, double-blind, placebo-controlled study of efficacy and safety. Am. J. Gastroenterol., 2001, 96(1), 27-34.
[http://dx.doi.org/10.1111/j.1572-0241.2001.03443.x] [PMID: 11197282]
[30]
Qi, Q.; Wang, R.; Liu, L.; Zhao, F.; Wang, S. Comparative effectiveness and tolerability of esomeprazole and omeprazole in gastro-esophageal reflux disease: A systematic review and meta-analysis. Int. J. Clin. Pharmacol. Ther., 2015, 53(10), 803-810.
[http://dx.doi.org/10.5414/CP202396] [PMID: 26329348]
[31]
Lind, T.; Rydberg, L.; Kylebäck, A.; Jonsson, A.; Andersson, T.; Hasselgren, G.; Holmberg, J.; Röhss, K. Esomeprazole provides improved acid control vs. omeprazole In patients with symptoms of gastro-oesophageal reflux disease. Aliment. Pharmacol. Ther., 2000, 14(7), 861-867.
[http://dx.doi.org/10.1046/j.1365-2036.2000.00813.x] [PMID: 10886041]
[32]
Waldum, H.L.; Qvigstad, G.; Fossmark, R.; Kleveland, P.M.; Sandvik, A.K. Rebound acid hypersecretion from a physiological, pathophysiological and clinical viewpoint. Scand. J. Gastroenterol., 2010, 45(4), 389-394.
[http://dx.doi.org/10.3109/00365520903477348] [PMID: 20001749]
[33]
Strand, D.S.; Kim, D.; Peura, D.A. 25 years of proton pump inhibitors: A comprehensive review. Gut Liver, 2017, 11(1), 27-37.
[http://dx.doi.org/10.5009/gnl15502] [PMID: 27840364]
[36]
Prabu, S.L.; Suriyaprakash, T.N.K. Extraction of drug from the biological matrix: A review. In: Applied Biological Engineering - Principles and Practice; Naik, G.R., Ed.; IntechOpen: London, 2012; pp. 479-506.
[http://dx.doi.org/10.5772/32455]
[37]
Atole, D.M.; Rajput, H.H. Ultraviolet spectroscopy and its pharmaceutical applications- a brief review. Asian J. Pharm. Clin. Res., 2018, 11(2), 59-66.
[http://dx.doi.org/10.22159/ajpcr.2018.v11i2.21361]
[38]
Pilaniya, K.; Chandrawanshi, H.K.; Pilaniya, U.; Manchandani, P.; Jain, P.; Singh, N. Recent trends in the impurity profile of pharmaceuticals. J. Adv. Pharm. Technol. Res., 2010, 1(3), 302-310.
[http://dx.doi.org/10.4103/0110-5558.72422] [PMID: 22247862]
[39]
Currell, G. Analytical Instrumentation Performance Characteristics, 1st ed.; Wiley, J., & sons Ltd.: Hoboken, New Jersey, 2000, p. 67.
[40]
Cazes, J.; Dekker, M. Ewings’s Analytical instrumentation handbook, 3rd ed; Marcel dekker: New York, 2005, p. 127.
[41]
Beckett, A.H.; Stenlake, J.B. Practical Pharmaceutical Chemistry, 4th ed.; CBS publication: Tamil Nadu, India, 1997, p. 284.
[42]
Patel, P.; Patel, D.; Desai, S.; Meshram, D. Development and validation of analytical methods for simultaneous estimation of difluprednate and gatifloxacin in ophthalmic emulsion By Uv-visible spectroscopy. Int. J. Pharm. Sci. Invent., 2014, 3(4), 1.
[43]
Samir, A.; Salem, H.; Abdelkawy, M. New developed spectrophotometric method for simultaneous determination of salmeterol xinafoate and fluticasone propionate in bulk powder and Seritide® diskus inhalation. Bull. Fac. Pharm. Cairo Univ., 2012, 50(2), 121-126.
[http://dx.doi.org/10.1016/j.bfopcu.2012.07.006]
[44]
Tabbouche, O.S.; Soukkariyyeh, I. First-order derivative ultraviolet spectrophotometry of imipenem E cilastatin formulations. J. Taibah Univ. Med. Sci., 2014, 9(3), 178-181.
[http://dx.doi.org/10.1016/j.jtumed.2014.01.006]
[45]
Rajput, S.; Raj, H. Simultaneous estimation of ezetimibe and lovastatin by derivative spectroscopy. Int. J. Pharm. Tech. Res., 2009, 1(3), 894-899.
[46]
Attimarad, M.; Al-Dhubiab, B.E.; Alhaider, I.A.; Nair, A.B. N, S.H.; K, M.A. Simultaneous determination of moxifloxacin and cefixime by first and ratio first derivative ultraviolet spectrophotometry. Chem. Cent. J., 2012, 6(1), 105-111.
[http://dx.doi.org/10.1186/1752-153X-6-105] [PMID: 22995678]
[47]
Patel, B.; Jadav, A.; Solanki, H.; Parmar, S.; Parmar, V.; Captain, A. Development and validation of derivative spectroscopic method for the simultaneous estimation of rosuvastatin calcium and fenofibrate in tablet. Int. J. Pharma Res. Rev., 2013, 2(7), 1-6.
[48]
Pandey, G.; Mishra, B. A new analytical Q-absorbance ratio method development and validation for simultaneous estimation of lamivudine and isoniazid. Int. Sch. Res. Notices, 2013, 2013, 1-5.
[49]
Rahman, N.; Bano, Z.; Azmi, S.N.H. Spectrophotometric determination of esomeprazole magnesium in commercial tablets using 5-sulfosalicylic acid and N-bromosuccinimide. J. Chin. Chem. Soc. (Taipei), 2008, 55(3), 557-566.
[http://dx.doi.org/10.1002/jccs.200800082]
[50]
Mandil, H.; Sakur, A.A.; Allabban, A.A. New sensitive spectrophotometric methods for determination of esomeprazole magnesium trihydrate in dosage forms. Int. J. Pharm. Pharm. Sci., 2013, 5(4), 747-751.
[51]
Purushotham, R.M.; Raveendra, R.P.; Reddy, N.R. Simple spectrophotometric determination of esomeprazole magnesium in pharmaceutical formulations. Asian J. Pharm. Hea. Sci., 2011, 1(3), 135-136.
[52]
Alhfidh, H.A.; Othman, N.S. Application of the cloud point extraction method in spectrophotometric estimation of esomeprazole using diazotised p-nitroaniline and triton X-114. Egypt. J. Chem., 2021, 64(11), 6242-6249.
[53]
Rasheed, S.; Dev, S.; Remya, K.; Jacob, J.; Rani, S. Determination of esomeprazole by complexation method. Der. Pharma Chem., 2017, 9(22), 101-105.
[54]
Narwal, S.N.; Saini, V.P. Preformulation, characterization, estimation and method validation studies of esomeprazole magnesium trihydrate by UV-visible spectrophotometry. Int. J. Pharm. Res. Scholars, 2016, 5(1), 151-161.
[55]
Kumar, P.R.; Shyale, S. M, M. G.; Kumar, S. M. S Physico-chemical characterization, UV spectrophotometric method development and validation studies of esomeprazole magnesium trihydrate. J. Chem. Pharm. Res., 2010, 2(3), 484-490.
[56]
Jhansi, K.; Chiranjeevi, P.; Vara, P.R.K.; Srinivasa, R.Y.; Deepthi, R. A validated UV spectrophotometric method for the estimation of esomeprazole magnesium trihydrate in bulk and commercial dosage form. J. Glob. Trends Pharm. Sci., 2020, 11(4), 8754-8760.
[57]
Jain, N.; Kulkarni, S.; Jain, D.K.; Jain, S.K. Spectrophotometric methods for simultaneous estimation of esomeprazole magnesium and naproxen in a tablet dosage form. Acta Pol. Pharm., 2012, 69(6), 1195-1199.
[PMID: 23285682]
[58]
Gohil, D.; Rajput, S.J. Simultaneous estimation of diclofenac sodium and esomeprazole magnesium trihydrate in bulk drug and in synthetic mixture by spectrophotometry. Int. J. Pharm. Sci. Res., 2013, 4(6), 2435-2440.
[59]
Patel, R.; Kakadiya, J.; Patel, P.; Shah, N. Development and validation of second order derivative spectrophotometric method for simultaneous estimation of levosulpiride and esomeprazole in combined pharmaceutical formulation. Int. J. Pharma Bio Sci., 2014, 3(2), 785-798.
[60]
Zareh, M.M.; Saad, M.Z.; Hassan, W.S.; Elhennawy, M.E.; Sebaiy, M.M. Validation of spectrophotometric method for determination of esomeprazole and ciprofloxacin in their pure and dosage forms. Int. J. Pharm. Sci. Dev. Res., 2020, 6(1), 1-5.
[http://dx.doi.org/10.17352/ijpsdr.000024]
[61]
United states pharmacopeial convention. The United States Pharmacopeia, 20th revision: The National Formulary, 15th ed; The Convention: Rockville, Md, 1979.
[62]
Malviya, R.; Bansal, V.; Pal, O.P.; Sharma, P.K. High performance liquid chromatography: A short review. J. Glob. Pharma Technol., 2010, 2(5), 22-26.
[63]
Martin, M.; Guiochon, G. Effects of high pressure in liquid chromatography. J. Chromatogr. A, 2005, 1090(1-2), 16-38.
[http://dx.doi.org/10.1016/j.chroma.2005.06.005] [PMID: 16196131]
[64]
Snyder, L. R.; Kirkland, J. J. Introduction to Modern Liquid Chromatography; John Wiley & Sons, INC.: Hoboken, New Jersey, 1979, p. 130.
[65]
Kealey, D.; Haines, P.J. Instant Notes: Analytical Chemistry; BIOS Scientific Publishers: Oxford, 2002, 80, p. (3)156.
[http://dx.doi.org/10.4324/9780203645444]
[66]
Lakshmi, K.; Rajesh, T. Determination of voglibose in pharmaceutical formulations by high performance liquid chromatography using refractive index detection. Eur. J. Chem., 2010, 1(4), 262-265.
[http://dx.doi.org/10.5155/eurjchem.1.4.262-265.116]
[67]
Ulu, S.T.; Tuncel, M. Determination of bupropion using liquid chromatography with fluorescence detection in pharmaceutical preparations, human plasma and human urine. J. Chromatogr. Sci., 2012, 50(5), 433-439.
[http://dx.doi.org/10.1093/chromsci/bms020] [PMID: 22454390]
[68]
TNVSS S.; Sudhir, KVR.; Santosh, T.; Sundar, B. S. Development and validation of high-performance liquid chromatographic method for the determination of Esomeprazole in human plasma. Int. J. Res. Pharm. Chem., 2013, 3(3), 552-559.
[69]
Fatema, M.; Suriya, S.; Satyajit, R.R.; Farhana, A.; Shammi, A.; Sohrab, M.H. Bioanalytical method validation of Esomeprazole by high performance liquid chromatography with PDA detection. Acta Chromatogr., 2021, 33(2), 120-126.
[http://dx.doi.org/10.1556/1326.2020.00769]
[70]
Jain, V.; Shah, V.K.; Jain, P.K. HPLC Method development and validation for the estimation of esomeprazole in bulk and pharmaceutical dosage form. J. Drug Deliv. Ther., 2019, 9(4), 292-295.
[71]
Khanam, P.S.; Agarwal, N.K.; Sultana, Y. Development and validation of RP-HPLC method for acid resistance and assay of esomeprazole magnesium in esomeprazole magnesium pellets. Int. J. Pharm. Chem. Sci, 2013, 2(1), 500-504.
[72]
Muhammad Ranjha, N.; Rashid, Z.; Razzaq, R.; Raza, H.; Hanif, M.; Mahmood, A. Development and validation of fast reversed-phase HPLC method for analysis of Esomeprazole in rabbit plasma. Acta Pol. Pharm., 2017, 74(2), 385-391.
[PMID: 29624243]
[73]
Harahap, Y.; Baskara, A.E. H, H.; Baskara, A. E.; Harmita, Method validation of esomeprazole analysis in human plasma using high performance liquid chromatography-photodiode array. J. Young Pharm., 2017, 9(1), 24-28.
[http://dx.doi.org/10.5530/jyp.2017.1s.7]
[74]
Gawande, V.; Puranik, M. Development and validation of RP HPLC method for estimation of esomeprazole magnesium in solid dosage form. J. Pharm. Res., 2012, 5(10), 5074-5075.
[75]
Alex, D.C.; Vembu, P.; Dhanalakshmi, K. Validated RP-HPLC method for the estimation of esomeprazole enteric coated tablets. Pharma Chem., 2017, 9(10), 75-79.
[76]
Shanmugakumar, S.D.; Begum, A.N.; Uday, B. A novel RP-HPLC method for determination of esomeprazole in pharmaceutical dosage forms in human plasma: A pilot stress degradation study. Asian J. Pharm. Ana., 2021, 11(1), 9-16.
[http://dx.doi.org/10.5958/2231-5675.2021.00002.8]
[77]
Khalil, M.T.; Usman, M.; Khan, G.M.; Awan, S.B.; Bibi, H.; Siddiqua, A. HPLC Method development and validation for the estimation of esomeprazole in bulk and pharmaceutical dosage form. Int. J. Drug Dev. & Res., 2012, 4(4), 252-256.
[78]
Rao, M. N.; Krishna, K. B. M; Babu, B. H. J. Development and validation of a stability indicating hplc method for the simultaneous analysis of esomeprazole and itopride in bulk and in capsules. J. Appl. Pharm. Sci, 2016, 6(02), 072-080.
[http://dx.doi.org/10.7324/JAPS.2016.60210]
[79]
Gohil, D.; Bhamre, P.; Jain, R.; Rajput, S. Simultaneous estimation of esomeprazole magnesium trihydrate, itopride hydrochloride and mosapride citrate by RP-HPLC method: Optimization, development, validation and application to laboratory sample. Int. J. Pharm. Sci. Res., 2014, 5(3), 907-912.
[80]
Jain, N.; Jain, R.; Jain, D.K.; Jain, S.K. RP-HPLC method for simultaneous estimation of esomeprazole magnesium and domperidone in a tablet dosage form. Bull. Pharm. Res., 2012, 2(3), 134-139.
[81]
Thamizhanban, D.; Krishnaswamy, K.; Gampa, T.R. RP-HPLC method development and validation for simultaneous estimation and forced degradation studies of Naproxen and Esomeprazole magnesium in delayed release dosage form. Int. Res. J. Pharm., 2019, 10(10), 31-40.
[http://dx.doi.org/10.7897/2230-8407.1010295]
[82]
Kumar, S.A.; Debnath, M.; Rao, J.V.L.N.S.; Sankar, D.G. A new bioanalytical method development & validation for simultaneous estimation of esomeprazole and naproxen in human plasma by using RP-HPLC. Br. J. Pharm. Res., 2014, 4(19), 2312-2327.
[http://dx.doi.org/10.9734/BJPR/2014/10918]
[83]
Ali, A.S.A.; Ali, O.I.M.; Farag, A.F.B.; Khalek, M.F.A. Development and validation of high-performance liquid chromatography for the determination of domperidone and esomeprazole in their pharmaceutical formulation. Am. J. Pharm Health Res, 2018, 6(2), 37-48.
[http://dx.doi.org/10.46624/ajphr.2018.v6.i2.004]
[84]
Razzaq, S.N.; Ashfaq, M.; Khan, I.U.; Mariam, I. Development and validation of liquid chromatographic method for naproxen and esomeprazole in binary combination. J. Chil. Chem. Soc., 2012, 57(4), 1456-1459.
[http://dx.doi.org/10.4067/S0717-97072012000400024]
[85]
Kayesh, R.; Sultan, M.Z. A novel ion-pair RP-HPLC method for simultaneous quantification of naproxen and esomeprazole in pharmaceutical formulations. J. Chromatogr. Sci., 2015, 53(5), 687-693.
[http://dx.doi.org/10.1093/chromsci/bmu103] [PMID: 25182005]
[86]
Patel, D.; Patel, N.; Vaisay, R.; Patel, V.; Solanki, C.; Patel, M. Development and validation of RP-HPLC method for simultaneous estimation of aspirin and esomeprazole magnesium in tablet dosage form. J. Chem., 2012, 2013, 1-5.
[http://dx.doi.org/10.1155/2013/751940]
[87]
Venkateswara, R.A.; Sandya, S.; Vasavi, P.; Sunitha, G.; Panikumar, D.A. Simple and rapid liquid chromatographic method for real-time quantification of naproxen/esomeprazole magnesium combination tablets. J. App. Pharm., 2014, 6(1), 36-42.
[88]
Sojitra, C.; Rajput, S. Development and validation of RP-HPLC methods for simultaneous estimation of naproxen and esomeprazole magnesium trihydrate in combined pharmaceutical formulation. Int. J. Pharm. Pharm. Sci., 2012, 4(3), 533-537.
[89]
Kulkarni, R.N.; Pandhare, R.B.; Deshmukh, V.K.; Mohite, P.B.; Pawar, A.R. High-performance thin layer chromatography: A powerful analytical technique in pharmaceutical drug discovery. J. Pharm. Biol. Sci., 2021, 9(1), 7-14.
[http://dx.doi.org/10.18231/j.jpbs.2021.002]
[90]
Gosavi, S.M.; Tayade, M.A. Development and validation of high-performance thin layer chromatography for determination of esomeprazole magnesium in human plasma. J. Chromatogr. Sep. Tech., 2017, 8(2), 1-5.
[91]
Gosavi, S.A.; Bhavar, G.B.; Chepurwar, S.B.; Shirkhedkar, A.A.; Bari, S.B.; Surana, S.J. Estimation of esomeprazole in bulk and tablet dosage form by use of planar chromatography. Res. J. Pharm. Tech., 2010, 3(4), 1185-1188.
[92]
Sharma, S.; Sharma, M.C. Densitometric method for the quantitative determination of esomeprazole and domperidone in dosage forms. J. Toxicol. Sci., 2011, 3(3), 143-148.
[93]
Shaikh, N.C.; Kadam, A.M.; Bandgar, S.A.; Dhaneshwar, S.R. Method development and validation for simultaneous estimation of Esomeprazole and Domperidone as bulk drugs and in tablet dosage form by HPTLC. Int. J. Res. Ayurveda Pharm., 2012, 3(3), 421-424.
[94]
Gawande, V.; Puranik, M. Development and validation of HPTLC method for simultaneous estimation of domperidone in combination with esomeprazole magnesium in solid dosage form. Int. J. Chem. Sci., 2009, 7(2), 791-796.
[95]
Roosewelt, C.; Magesh, A.R.; Rekha, A.G.S.; Pandian, P.S.; Gunasekaran, V. Simultaneous estimation and validation of esomeprazole and domperidone by HPTLC in pure and pharmaceutical dosage forms. Asian J. Chem., 2007, 19(4), 2955-2960.
[96]
Pitt, J.J. Principles and applications of liquid chromatography-mass spectrometry in clinical biochemistry. Clin. Biochem. Rev., 2009, 30(1), 19-34.
[PMID: 19224008]
[97]
Hultman, Ia.; Stenhoff, H.; Liljeblad, M. Determination of esomeprazole and its two main metabolites in human, rat and dog plasma by liquid chromatography with tandem mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2007, 848(2), 317-322.
[http://dx.doi.org/10.1016/j.jchromb.2006.10.074] [PMID: 17142113]
[98]
Mogili, R.; Kanala, K.; Bannoth, C.K.; Chandu, B.R.; Challa, S.R. Quantification of Esomeprazole in human plasma by liquid chromatography tandem mass spectrometry and its application to bioequivalence study. Pharm. Lett., 2011, 3(5), 138-145.
[99]
Chunduri, R.H.B.; Dannana, G.S. Development and validation of a high throughput UPLC-MS/MS method for simultaneous quantification of esomeprazole, rabeprazole and levosulpiride in human plasma. J. Pharm. Anal., 2016, 6(3), 190-198.
[http://dx.doi.org/10.1016/j.jpha.2016.01.001] [PMID: 29403981]
[100]
Skoog, D.A.; Donald, M.W.; Holler, F.J. Fundamentals of Analytical Chemistry, 7th ed.;
[101]
Radi, A.E.; Abd-Elkader, A. Voltammetric behaviour of esomeprazole at screen printed carbon electrode and its determination in capsule dosage form. Eurasian J. Anal. Chem., 2015, 9(2), 92-101.
[102]
Assaf, H.F.; Salah, H.; Hashem, N.; Khodari, M. Voltametric determination of esomeprazole using carbon paste electrode modified by nanoparticles oxide, and its application on tablet and serum. Int. J. Eng. Res. Technol. (Ahmedabad), 10(2), 229-237.
[103]
Naresh, K. JCHPS special issue 5. Available from: 2014www.jchps.com
[104]
Belal, F.; Sharaf El-Din, M.; Tolba, M.M.; Alaa, H. Enhanced spectrofluorimetric determination of esomeprazole and pantoprazole in dosage forms and spiked human plasma using organized media. Luminescence, 2015, 30(3), 343-351.
[http://dx.doi.org/10.1002/bio.2737] [PMID: 25060291]
[105]
Alshareef, A.A.; Elwahid, E.O.A.; Yousif, A.E.; Abdelgader, H.; Gaily, M.M.; Abdelwahid, M.A.S. Development and validation of complexometric titrimetric method for estimation of esomeprazole magnesium in magnesium in bulk and tablet dosage form. Elixir Pharm., 2016, 100, 43684-43687.
[106]
Beg, S.; Haneef, J.; Rahman, M.; Perman, R.; Taleuzzaman, M.; Almalki, W.H. Handbook of Analytical Quality by Design; Academic Press: Cambridge, Massachusetts, 2021, pp. 1-14.
[107]
Chanduluru, H.K.; Sugumaran, A. Eco-friendly estimation of isosorbide dinitrate and hydralazine hydrochloride using green analytical quality by design-based UPLC method. RSC Advances, 2021, 11(45), 27820-27831.
[http://dx.doi.org/10.1039/D1RA04843K]
[108]
Hicks, M.B.; Farrell, W.; Aurigemma, C.; Lehman, L.; Weisel, L.; Nadeau, K.; Lee, H.; Ginsburg-Moraff, C.; Wong, M.; Huang, Y.; Ferguson, P. Making the move towards modernized greener separations: Introduction of the analytical method greenness score (AMGS) calculator. Green Chem., 2019, 21(7), 1816-1826.
[http://dx.doi.org/10.1039/C8GC03875A]

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