分析与生物分析技术杂志

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Validated HPTLC Method for Simultaneous Estimation of Metformin Hydrochloride, Atorvastatin and Glimepiride in Bulk Drug and Formulation

Sunil R. Dhaneshwar, Janaki V. Salunkhe and Vidhya K. Bhusari

This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous estimation of Metformin hydrochloride (MET), Atorvastatin (ATV) and Glimepiride (GLM) as the bulk drug and in tablet dosage forms. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F 254 as the stationary phase and the solvent system consisted of water: methanol: ammonium sulphate (1: 1: 4 v/v/v). Densitometric evaluation of the separated zones was performed at 237 nm. The three drugs were satisfactorily resolved with R F values 0.37 ± 0.02 and 0.59 ± 0.02, 0.75 ± 0.02 for MET, ATV, GLM respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (200-700 ng/spot for MET, 600-2100 ng/spot for ATV and 600-2100 ng/spot for GLM ), precision (intra-day% RSD was 0.54–1.23 and inter-day% RSD was 0.90–1.48 for MET, intra-day% RSD was 0.91–1.74 and inter-day% RSD was 0.56–1.52 for ATV and intra-day% RSD was 0.60–1.27 and inter-day% RSD was 0.96–1.48 for GLM ), accuracy (99.66 ± 0.14 for MET, 98.46 ± 0.40 for ATV and 98.62 ± 0.39 for GLM ), and specificity in accordance with ICH guidelines.