Validated Hptlc Method for Simultaneous Estimation of Metformin Hydrochloride and Sitagliptin Phosphate in Bulk Drug and Formulation
نویسندگان
چکیده
A new simple high performance thin layer chromatographic method for simultaneous determination of antidiabetic drugs, metformin hydrochloride and sitagliptin phosphate in bulk and tablet dosage form were investigated. Chromatographic separation of the drugs were performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of acetone:methanol:toluene:formic acid (4:3:2:1 v/v/v/v). Densitometric evaluation of the separated zones was performed at 220 nm and the method was validated. The Rf values and drug content of metformin hydrochloride and sitagliptin phosphate were 0.36±0.02, 0.63±0.02 and 100.1%, 99.84% respectively. The calibration curves of peak area versus concentration, which were linear from 2000-5000 ng per band for metformin hydrochloride, 200-500 ng per band for sitagliptin phosphate and regression coefficient(r 2 ) was greater than 0.99. LOD for metformin hydrochloride and sitagliptin phosphate was 45 and 27 ng per band respectively, while LOQ was 150 and 87 ng per band respectively. The method was validated for linearity, accuracy, robustness and application for assay as per ICH guidelines. The study shows that the developed method is simple and accurate and it would be suitable for the simultaneous determination of metformin hydrochloride and sitagliptin phosphate in bulk drug and pharmaceutical formulations.
منابع مشابه
Development and Validation of a Method for Simultaneous Determination of Metformin Hydrochloride and Sitagliptin Phosphate in a Formulation by RP-HPLC
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