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Development and validation of the liquid chromatographic method for simultaneous estimation of metformin, pioglitazone, and glimepiride in pharmaceutical dosage forms

Submitted by webadmin on Wed, 10/19/2016 - 12:20
Pharmaceutical Methods,2012,3,1,9-13.
Published:January 2012
Type:Original Article

Development and validation of the liquid chromatographic method for simultaneous estimation of metformin, pioglitazone, and glimepiride in pharmaceutical dosage forms

Vinay Pandit, Roopa S. Pai, Kshama Devi1, Gurinder Singh, Satya Narayana2, Sarasija Suresh3

Department of Pharmaceutics, 1Quality Improvement cell, 2Quality Assurance, Al-Ameen College of Pharmacy, Bangalore, Karnataka, 3Department of Pharmaceutical Technology (Formulations), NIPER, Mohali, Punjab, India

Abstract:

Introduction: A simple, precise, and accurate HPLC method for simultaneous estimation of metformin hydrochloride (MET), pioglitazone hydrochloride (PIO), and glimepiride (GLIMP) was developed and validated. Materials and Methods: Chromatographic separation of the drugs was performed by using a Phenomenex-ODS-3 (C-18) column (250 × 4.60 mm, 5 μm) with a mobile phase consisting of methanol:acetonitrile:15 mM potassium dihydrogen phosphate (pH 4) in the proportion of 40:35:25 (v/v) at a flow rate of 1 ml/min. Detection was carried out using a UV-SPD-10AVP detector at 240 nm. Results: The retention time for MET, PIO, and GLIMP were 2.85 ± 0.03 min, 4.52 ± 0.03 min, and 7.08 ± 0.02min, respectively. Parameters such as linearity (0.2– 50 μg/ ml for MET, 0.2–30 μg/ml for PIO, and GLIMP, respectively), precision (intra-day % RSD was 1.01–3.24 and inter-day % RSD was 1.54–4.09 for MET; intra-day % RSD was 1.03–2.09 and inter-day % RSD was 2.26–3.10 for PIO; and intra-day% RSD was 1.00–3.15 and inter-day % RSD was 1.58–3.07 for GLIMP), accuracy (99.66 ± 0.14 for MET, 98.46 ± 0.40 for PIO, and 98.62 ± 0.39 for GLIMP), specificity and robustness were calculated in accordance with ICH guidelines. Conclusions: The method was proved to be simple, rapid, precise, accurate, and cost effective.

Structures of three anti-diabetic drugs