Method development and validation for the simultaneous estimation of sitagliptin and metformin in tablet dosage form by RP-HPLC
Journal Title: International Journal of Pharmacy and Analytical Research - Year 2014, Vol 3, Issue 4
Abstract
A RP-HPLC method was developed and validated for the simultaneous estimation of Metformin Hydrochloride (MET) and Sitagliptin (STG) in pure and pharmaceutical dosage form. Chromatography was carried on Phenomex (kromosil-250 mm × 4.6 mm, 5 μm) column with mobile phase comprising of phosphate buffer and acetonitrile in the ratio 75:25 v/v. The flow rate was adjusted to 1.0 ml/min with UV detection at 260 nm. The retention times of MET and STG were found to be 1.43 min, 2.3 min respectively. The different analytical parameters such as accuracy, linearity, precision, robustness, limit of detection (LOD), limit of quantification (LOQ) were determined according to the ICH-Q2B guidelines. The detector response was linear in the range of 25-250 μg/ml, 2.5-25 μg/ml for MET, STG respectively. The proposed RP-HPLC method is sensitive, precise and accurate so it was successfully applied for the reliable quantification of drugs in the commercial dosage form.
Authors and Affiliations
B Thangabalan
Keywords
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