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Analytical method development and validation of hydrocortisone and clotrimazole in topical dosage form using RP-HPLC
Future Journal of Pharmaceutical Sciences ( IF 3.4 ) Pub Date : 2020-08-05 , DOI: 10.1186/s43094-020-00065-7
Dure Najaf Iqbal , Adeel Ashraf , Munawar Iqbal , Arif Nazir

Different pharmaceutical topical agents are available in the market for the treatment of fungal infections. A simple, precise, and cost-effective RP-HPLC method was developed and validated for the determination of hydrocortisone and clotrimazole simultaneously in a topical cream dosage form. Chromatographic separation was done on USP L1 (250 × 4.6) mm column with a particle size of 5 μm. The mobile phase employed for this study consists of acetonitrile and buffer in the ratio of 75:25, respectively. The flow rate was kept at 1 mL per minute. The detection of the drug was carried out at 254 nm using a UV detector. The retention times of HYD and CL were 3.0 min and 7.3 min, respectively. The method is developed and validated for linearity, precision, specificity, accuracy, and robustness. The stability of finished products gives us knowledge about the effect of different environmental factors like humidity, light, and temperature, and these factors give us information about the quality of finished products.

中文翻译:

RP-HPLC分析方法开发和验证局部剂型中的氢化可的松和克霉唑

市场上可以买到不同的药物局部用药来治疗真菌感染。开发了一种简单,精确且经济高效的RP-HPLC方法,并已验证该方法可同时测定局部乳膏剂型中的氢化可的松和克霉唑。色谱分离是在粒径为5μm的USP L1(250×4.6)mm色谱柱上进行的。本研究使用的流动相分别由比例为75:25的乙腈和缓冲液组成。流速保持在每分钟1mL。使用UV检测器在254nm处进行药物的检测。HYD和CL的保留时间分别为3.0分钟和7.3分钟。该方法的线性度,精度,特异性,准确性和鲁棒性得到开发和验证。
更新日期:2020-08-05
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