A Validated High Performance Liquid Chromatography Method for the Determination of Saxagliptin and Metformin in Bulk and Pharmaceutical Dosage Form, a Stability Indicating Study
Journal Title: IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) - Year 2016, Vol 11, Issue 6
Abstract
A Stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Saxagliptin (SAX) and Metformin (MET) in bulk and pharmaceutical dosage form. The separation was carried on kromasil- C18 column (4.5 x 250 mm; 5 µm) column with mobile phase consisting of 50mM sodium dihydrogen phosphate buffer (pH adjusted to 2.7 using orthophosphoric acid): methanol in the ratio of 80:20 v/v with a flow rate of 0.9 ml/min and PDA detection at 242nm. The linearity was found to be in range of 0.5-3 µg/mL (R2 = 0.9995) and 50-300 µg/mL (R2 = 0.9995) for SAX and MET respectively. The method has shown good, consistent recoveries for SAX 98.39-101.53% and MET 100.46 -101.59% respectively. The method was found to be accurate, precise, specific, robust and linear for the determination of SAX and MET in bulk and pharmaceutical dosage form.
Authors and Affiliations
Ramesh J, Dr. Senthil Kumar N
Keywords
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- DOI 10.9790/3008-11060392100
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