Abstract

A NEW METHOD DEVELOPMENT AND VALIDATION OF METFORMIN HCL AND SITAGLIPTIN BY RP-HPLC AND PHARMACEUTICAL FORMULATIONS

Srikanth B.*, Venkata Ramana K. and M. Prasada Rao

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Abstract

A simple rapid and precise Rp-hplc method for metaformin HCL in a pharmaceutical solid dosage form has been developed and validated. Chromatography was performed on a 250 × 4.6mm i.d 4g particle C18 Column with di potassium hydrogen phosphate and Acetonitrile 55:45% V/V) PH-4.5 with orthophosphoric acid buffer as mobile phase at a flow rate of 1ml/min. UV detection was performed at 260nm.Run time 10 min; metaformin HCL retension time is 4.28. The method was validated for accuracy, precision, linearity, LOD, LOQ, Robustness, Ruggedness, specificity, and sensitivity in accordance with ICH guide lines. Validation revealed the method is specific, rapid, accurate, precise, reliable and reproducible. Calibration plot was linear over the concentration ranges 20mg/ ml for metaformin HCL. Limit of detection is1.05 μg and limit of quantification is 5.6 μg for metaformin HCL. The high recovery and low coefficients of variation confirm the suitability of the method for metaformin HCL in tablets. The validated method was successfully used for quantitative analysis of metaformin HCL tablets. Find out the impurities of given metaformin HCL by using the validated method with help of HPLC.

Keywords: HPLC analysis, Method development, RP-HPLC, Validation, Impurities, metaformin HCL, di potassium hydrogen phosphate, orthophosphoric acid.