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Validated HPLC and stability-indicating densitometric chromatographic methods for simultaneous determination of camylofin dihydrochloride and paracetamol in their binary mixture

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Abstract

Two accurate, sensitive, precise and selective HPLC and stability-indicating TLC methods were developed for the simultaneous determination of camylofin-2HCl and paracetamol. Forced acid, alkali and oxidative degradation of camylofin-2HCl were tried where complete degradation was achieved using 5 N HCl. HPLC method was developed to determine the mixture of the two drugs using Zorbax NH2 column and a mobile phase of 0.5% triethylamine and pH 3.0 adjusted with 0.1% phosphoric acid and methanol (70:30 v/v) over concentration ranges of 3–90 and 10–95 µg/mL for camylofin-2HCl and paracetamol, respectively.TLC method was used for the separation of camylofin from its acid degradate and paracetamol using chloroform–methanol–acetone–conc. ammonia (8:2:2:0.1, by volume) as developing system and band scanning at 254 nm over concentration ranges of 5–40 µg/band for camylofin-2HCl and 0.1–0.5 µg/band for paracetamol. The validation of two methods was carried out according to ICH guideline. Accuracy ranged between 98.47 and 100.67% for the two methods with acceptable precision RSD% ranging between 0.66 and 1.47%.

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Authors and Affiliations

  1. Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt

    Sawsan A. Abdel Razeq & Israa A. Khalil

  2. National Organization for Drug Control and Research (NODCAR), Giza, Egypt

    Samah A. Mohammd

Authors
  1. Sawsan A. Abdel Razeq
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  2. Israa A. Khalil
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  3. Samah A. Mohammd
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Correspondence to Israa A. Khalil.

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Abdel Razeq, S.A., Khalil, I.A. & Mohammd, S.A. Validated HPLC and stability-indicating densitometric chromatographic methods for simultaneous determination of camylofin dihydrochloride and paracetamol in their binary mixture. J IRAN CHEM SOC 17, 2587–2597 (2020). https://doi.org/10.1007/s13738-020-01953-8

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