高效液相色谱法测定联合剂型中某些活性分析物的开发与验证——在体外溶出度研究中的应用

Q3 Pharmacology, Toxicology and Pharmaceutics

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-06-25 DOI:10.25258/ijpqa.14.2.16

Mayuri N. Deshmukh, Vaibhav Uplanchiwar, V. M. Thakare, Namrata S. Mane, S. Gaikwad, N. Dighade, Hina. Mehta, R. Bakal, Prashant R. Umate

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引用次数: 0

摘要

本文介绍了一种新的、简单、准确、经济的高效液相色谱法的开发和验证方法，该方法用于评价盐酸二环胺与奥美拉唑镁联合剂型的含量。方法的初步开发试验采用C8（100×0.46×3.5μm）和C18 GraceSmart（250×4.6×5μm）作为固定相，乙酸缓冲液（pH 4.5）和甲醇作为流动相，比例为60:40v/v。影响因素的优化条件为样品大小50μL，波长（λmax）215 nm。然后将所开发的方法应用于盐酸二环胺和奥美拉唑镁的体外溶出度研究。根据ICH指南，进行了稳定性测试。该估算方法可用于制药行业产品的分析。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Development and Validation of HPLC Method for Estimation of Some Active Analytes in Combined Dosage form an Application to In-vitro Dissolution Studies

This paper describes a new, simple, accurate and economical method of development and validation of HPLC method for the assessment of dicyclomine hydrochloride with omeprazol magnesium combine dosage form. The method development trial was carried out initially using C8 (100×0.46×3.5 μm) and C18 GraceSmart (250×4.6×5 μm) as stationary phase and acetate buffer (pH 4.5) and methanol as mobile phase in proportion 60:40v/v. The optimized conditions of factors were sample size 50 μL and wavelength (λmax) 215 nm. The developed method was then applied to in-vitro dissolution studies for the dicyclomine hydrochloride and omeprazole magnesium. As per ICH guidelines, stability testing was done. The estimated method can be used to analyze the pharma industries’ products.

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来源期刊

International Journal of Pharmaceutical Quality Assurance Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

CiteScore

0.80

自引率

0.00%

发文量

期刊介绍： INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE is a quarterly international journal publishing the finest peer-reviewed research in the field of Pharmaceutical Quality Assurance and Pharmaceutical Analysis on the basis of its originality, importance, disciplinary interest, timeliness, accessibility, elegance, and surprising conclusions. IJPQA also provides rapid, authoritative, insightful and arresting news and interpretation of topical and coming trends affecting science, scientists and the wider public.