Validated HPTLC method for simultaneous estimation of voglibose and metformin hydrochloride in pharmaceutical dosage forms

The objective of present work was to develop validated HPTLC method for simultaneous estimation of voglibose and metformin hydrochloride in the bulk drug and tablet dosage forms. The chromatographic separation of the drugs was performed on aluminium plates precoated with silica gel 60 F₂₅₄ as the stationary phase and the solvent system consisted of ammonium sulphate (0.5%) : n- propanol (2:8;v/v). Densitometric evaluation of separated zones was performed at 248 nm. The two drugs were satisfactorily resolved with R_f values 0.20 ± 0.02 and 0.74 ± 0.02 for voglibose and metformin hydrochloride respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (200-1200 ng/spot for voglibose and 500-5000 ng/spot for metformin hydrochloride), precision (intra-day RSD 0.1379-0.3736% and inter-day RSD 0.4183-0.5706% for voglibose and intra-day RSD 0.2485-0.1355% and inter-day RSD 0.3740 -0.3150% for metformin hydrochloride), accuracy (100.69 ± 1.0% for voglibose and 101.57 ± 0.8% for metformin hydrochlo ride) and specificity in accordance with ICH guidelines. The proposed HPTLC method is less expensive, simpler, rapid and more precise than reported HPLC method for routine analysis of voglibose and metformin hydrochloride in bulk drug and tablet dosage forms.

Author(s): Charushila C. Shinde, Shakuntala S. Chopade and Suneela S. Dhaneshwar

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