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Title DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SAXAGLIPTIN AND METFORMIN IN TABLET DOSAGE FORM
Authors Asiya Begum, Shilpa K, A. Ajitha, V. Uma Maheshwar Rao
Description <div style="text-align: justify">A sensitive selective and precise stability indicating-high performance liquid chromatographic (HPLC) method was developed for Saxagliptin and Metformin in Tablet dosage form. An isocratic separation was carried out using Zorbax C18 (250 x 4.6 mm, 5 &micro;m) column and Potassium dihydrogen Phosphate: Methanol (60:40 v/v) as mobile phase.With quantification carried out at a wavelength of 248nm. The stability studies under stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation were also carried out for Saxagliptin and Metformin.The Retention time of Saxagliptin and Metformin were observed to be 3.241and 2.191 minutes, respectively with theoretical plate count and asymmetry as per the ICH limits. The % assay of Saxagliptin and Metformin were 99.640% and 99.021%. The flow rate was found to be 1ml/min .The linear regression analysis data for the calibration plots showed a good linear relationship for Saxagliptin and Metformin over a concentration range of 50-1500 &micro;g/ml with correlation co-efficient of 0.999 for Saxagliptin and 0.999 for Metformin. The limit of detection and Quantitation were found to be &nbsp;2.857,2.918&amp; 9.52,9.72&micro;g/ml, respectively.the method was validated as per ICH guidelines and it was found to be acccurate, precise and selective stability-indicating high performance liquid chromatographic (HPLC) &nbsp;for the determination of Saxagliptin and Metformin in tablet dosage form.&nbsp;</div>

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