Simultaneous estimation of pioglitazone, glimepiride & metformin hydrochloride in bulk & tablet dosage form by UV, RP-HPLC method

International Journal of Pharmaceutical Chemistry and Analysis Pub Date : 2021-10-15 DOI:10.18231/j.ijpca.2021.019

S. S. Shaikh, N. Dighe

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引用次数: 3

Abstract

A stability-indicating UV spectroscopic and high-performance liquid chromatography (RP-HPLC) method is developed for the quantification ofPioglitazone, Glimepiride & Metformin Hydrochloride drug substances. UV spectroscopic method was developed and validated, the wavelength selected for simultaneous estimation were 226nm for pioglitazone, 229nm for glimepiride and 232nm for metformin hydrochloride. The isosbestic point found for the analysis was 229nm. Selected mobile phase was a combination of methanol and water with a ratio of 70% Methanol and 30 % HPLC water with the flow rate of 0.85ml/min. The analyte was analysed on the C18 HPLC column having the pore size of 5 microns at room temperature. The method is validated according to ICH guidelines, the retention time of about 4.0min for metformin, 5.5min for Pioglitazone and 6.8min for Glimepiride was observed. The linearity range with regression co-efficient for Pioglitazone, Glimepiride & Metformin Hydrochloride is 3-15 μg/mL,0.4-1.2 μg/mL and 100-500 μg/mL and 0.9998, 0.9991, 0.9991 respectively.

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紫外、反相高效液相色谱法同时测定原料药和片剂中吡格列酮、格列吡脲、盐酸二甲双胍的含量

建立了吡格列酮、格列美脲和盐酸二甲双胍原料药的紫外光谱-高效液相色谱(RP-HPLC)定量方法。建立并验证了紫外分光光度法，同时测定的波长为吡格列酮226nm，格列美脲229nm，盐酸二甲双胍232nm。分析发现等吸点为229nm。选择流动相为甲醇与水的组合，甲醇比例为70%，HPLC水比例为30%，流速为0.85ml/min。室温条件下，采用孔径为5微米的C18高效液相色谱柱进行分析。方法按照ICH指南进行验证，二甲双胍保留时间约为4.0min，吡格列酮保留时间约为5.5min，格列美脲保留时间约为6.8min。吡格列酮、格列吡脲、盐酸二甲双胍的线性范围分别为3 ~ 15 μg/mL、0.4 ~ 1.2 μg/mL和100 ~ 500 μg/mL，回归系数分别为0.9998、0.9991、0.9991。

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International Journal of Pharmaceutical Chemistry and Analysis

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