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ISSN 2063-5346
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DEVELOPMENT AND VALIDATION OF RP HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HCL AND SITAGLIPTIN PHOSPHATE IN TABLET DOSAGE FORM

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Deepak M, Logeshwari T, Marina Juliet A, Vijey Aanandhi M
» doi: 10.31838/ecb/2023.12.1.347

Abstract

We developed and validated a simple, efficient, and less time-consuming analytical method for simultaneous estimation of metformin hydrochloride and sitagliptin phosphate in tablet dosage form by RP-HPLC. Chromatographic separation was accomplished in the isocratic mode using potassium dihydrogen phosphate and acetonitrile (70:30) as the mobile phase, nucleodur C18 (250mm x 4.6 mm) column as the stationary phase with a flow rate of 0.8 ml/min using an UV detector maintained at 267 nm. The reported periods of retention for metformin and sitagliptin are 2.8 min and 7.5 min respectively. As per ICH guidelines, this procedure has been validated for Specificity, Linearity and Range, Accuracy, System Precision, Method Precision, Intermediate Precision, Robustness, Solution stability and Filter Integrity. Our research focusses on reducing the complexity and duration of time required for analyzing metformin hydrochloride and sitagliptin phosphate tablets. The results obtained were good and found within the limit, proving that the developed method can be used for determination of metformin and sitagliptin tablets.

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