ABSTRACT

The main aim of the study is to develop a simple, rapid, accurate and precise method for the development and validation for the estimation of saxagliptin in bulk form and marketed pharmaceutical dosage form by using RP-UPLC method. The equipment used for this method is Ultra Performance Liquid Chromatography (UPLC) equipped with auto sample and PDA detector. The software used is Empower version-2. Xterra C18 (2.1 X 50 mn, 1.7µm) column is used with the flow rate 3ml/min. Detector is performed at the wavelength of 219nm. The retention time for Saxagliptin samples and standard is found to be 1.301 and 1.303 mins respectively. The calibration plots were linear over the concentration range of 20-100 µg/ml and the corelation co-efficient is found to be 0.999. There is no due to commonly used excipients. The %RSD for intermediate precision is found to be lower than 2.0% which obviously indicates that the present method is said to be highly precise. Regarding accuracy the % Recovery is found to be 99.8% which shows the method is accurate. This method is very sensitive with regard to LOD (0.030) and LOQ (0.090) respectively. The assay of marketed formulation is found to be 98.14463% which is within the limit. Thus, the developed RP-UPLC method was found to be simple, rapid, accurate, precise and highly suitable for routine analysis of drug samples containing Saxagliptin. Keywords: RP-UPLC, method validation, method development, saxagliptin, ICH guidelines
Publication date: 01/06/2022

https://ijbpas.com/pdf/2022/June/MS_IJBPAS_2022_6165.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.6.6165