Validated HPTLC Method Development for Simultaneous Estimation of Spironolactone and Hydrochlorothiazide in Formulation

IF 3 Q2 OPERATIONS RESEARCH & MANAGEMENT SCIENCE

International Journal of Management Science and Engineering Management Pub Date : 2022-06-13 DOI:10.36647/ijsem/09.06.a002

V. Bhusari, Nikita Jagtap, Utkarsh S. Bhosale, M. Ghante

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Abstract

This study describes a new TLC method for simultaneous quantification of Spironolactone and Hydrochlorothiazide in bulk and tablet dosage forms that is simple, precise and accurate. The drugs were separated using aluminium precoated plate with silica gel 60 F-254 as the stationary phase using Toluene: Ethyl acetate: Methanol 6: 4: 1 (v/v/v) as the mobile phase. At 231 nm, the separated zones were densitometrically evaluated. The two drugs were satisfactorily resolved with RF values of 0.78 ± 0.02 and 0.33 ± 0.02 for Spironolactone and Hydrochlorothiazide. The accuracy and reliability of the method were assessed by evaluation of linearity (120-270 ng/spot for Spironolactone and 100-350 ng/spot for Hydrochlorothiazide), precision (intra-day RSD 0.98-1.80 % and inter-day RSD 0.76-1.92 % for Spironolactone, and intra-day RSD 0.84-1.85 % and inter-day RSD 0.31-1.68 % for Hydrochlorothiazide), accuracy (100.78 ± 0.49 % for Spironolactone and 98.54 ± 1.80 % for Hydrochlorothiazide, by ICH guidelines. These methods have been applied to formulation and no interference of excipients is seen which proves that the method is specific.

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高效液相色谱法测定制剂中螺内酯和氢氯噻嗪的含量

本研究建立了一种简便、精确、准确的同时定量螺内酯和氢氯噻嗪原料药和片剂的新方法。以甲苯:乙酸乙酯:甲醇6:4:1 (v/v/v)为流动相，以硅胶60f -254为固定相，铝预涂板进行药物分离。在231 nm处，对分离区进行密度测定。螺内酯和氢氯噻嗪的RF值分别为0.78±0.02和0.33±0.02。按照ICH标准，通过线性(螺内酯120 ~ 270 ng/点，氢氯噻嗪100 ~ 350 ng/点)、精密度(螺内酯日内RSD 0.98 ~ 1.80%，日内RSD 0.76 ~ 1.92%，氢氯噻嗪日内RSD 0.84 ~ 1.85%，日内RSD 0.31 ~ 1.68%)、准确度(螺内酯100.78±0.49%，氢氯噻嗪98.54±1.80%)评价方法的准确性和可靠性。这些方法已应用于制剂中，未见辅料干扰，证明该方法具有特异性。

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来源期刊

International Journal of Management Science and Engineering Management OPERATIONS RESEARCH & MANAGEMENT SCIENCE-

CiteScore

8.50

自引率

33.30%

发文量

期刊介绍： International Journal of Management Science and Engineering Management (IJMSEM) is a peer-reviewed quarterly journal that provides an international forum for researchers and practitioners of management science and engineering management. The journal focuses on identifying problems in the field, and using innovative management theories and new management methods to provide solutions. IJMSEM is committed to providing a platform for researchers and practitioners of management science and engineering management to share experiences and communicate ideas. Articles published in IJMSEM contain fresh information and approaches. They provide key information that will contribute to new scientific inquiries and improve competency, efficiency, and productivity in the field. IJMSEM focuses on the following: 1. identifying Management Science problems in engineering; 2. using management theory and methods to solve above problems innovatively and effectively; 3. developing new management theory and method to the newly emerged management issues in engineering; IJMSEM prefers papers with practical background, clear problem description, understandable physical and mathematical model, physical model with practical significance and theoretical framework, operable algorithm and successful practical applications. IJMSEM also takes into account management papers of original contributions in one or several aspects of these elements.