Development and Validation of an HPLC Method for the Analysis of Saxagliptin in Bulk Powder

Dr. Pradnya Lokhande

Title:
Development and Validation of an HPLC Method for the Analysis of Saxagliptin in Bulk Powder

Authors:
Dr. Pradnya Lokhande

Cite This Article :

Dr. Pradnya Lokhande "Development and Validation of an HPLC Method for the Analysis of Saxagliptin in Bulk Powder" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-2, February 2020, pp.37-41, URL: https://www.ijtsrd.com/papers/ijtsrd29748.pdf

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Abstract :
The aim of this study was to develop a simple, rapid and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method for quantification of Saxagliptin in pharmaceutical bulk powder. The chromatographic system employs isocratic elution using a Cosmosil C18 (250mm x 4.6ID, Particle size: 5 micron). Mobile phase consisting of Methanol and water (70:30) set at flow rate 0.8 ml/min. The analyte was detected and quantified at 212nm using ultraviolet detector. The method was validated as per ICH guidelines. The standard curve was found to have a linear relationship (r2 > 0.99) over the analytical range of 10-50 µg/ml. For all quality control (QC) standards in intraday and interday assay, demonstrating the precision and accuracy over the analytical range. Samples were stable during preparation and analysis procedure. Therefore the rapid and sensitive developed method can be used for the routine analysis of Saxagliptin such as dissolution and stability assays of pre- and post-marketed dosage forms.

Keywords :
Saxagliptin, dipeptidyl peptidase-4 inhibitors, Diabetes mellitus

Publication Details:

Unique Identification Number : IJTSRD29748

Published In : Volume-4 | Issue-2, February 2020

Page Number(s) : 37-41

Publisher Name : IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470

Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

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