RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND SITAGLIPTIN IN TABLET DOSAGE FORMS
Journal Title: Int J of Pharm Res & Analy - Year 2013, Vol 3, Issue 1
Abstract
A new simple and precise reverse phase high performance liquid chromatographic method has been developed andsubsequently validated for the simultaneous estimation of Metformin and Sitagliptin in combination. The chromatographicseparation was performed in Waters equipment using mobile phase consisting of Potassium dihydrogen orthophosphate:Methanol in the ratio of 50:50 and the pH -4 adjusted by orthophosphoric acid. The column used was Hypersil BDS C 18, 5μ,150mm x 4.6 mm internal diameter with flow rate of 1 ml/min using PDA detection at 260 nm. The retention time was found tobe 1.773 min for Metformin and 3.696 min for Sitagliptin .The described method was found to be linear and correlationcoefficient was 0.999. Results of analysis were validated statistically and by recovery studies. Precision were performed as perICH guidelines with the result shows relative standard deviation not more than 2%. The assay value for Metformin andSitagliptin were found to be 99.89% and 99.94% respectively. The results of the study showed that the proposed RP-HPLCmethod is simple, rapid, precise, reliable, accurate and economical which is useful for the routine determination of Metforminand Sitagliptin bulk drug and in its pharmaceutical dosage form.
Authors and Affiliations
Rani Sirisha G , Vasanth PM , Ramesh T , Ramesh Malothu
Keywords
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- EP ID EP116236
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