Research paper of Method Development And Validation of Antidiabetic Drug  in its Pharmaceutical Dosage Form By Suitable Analytical Method

Research paper of Method Development And Validation of Antidiabetic Drug in its Pharmaceutical Dosage Form By Suitable Analytical Method
Author(s):
Ku. Papiha S. Tekade, Dr. Dipti B. Ruikar
Keywords:
Saxagliptin, Antidiabetic, HPLC, Method Development, Validation.
Abstract
The paper describes the invention of a simple, precise, and sensitive approach for detecting saxagliptin in bulk medication and marketed formulations using reverse-phase liquid chromatography. The separation was done on Epic C12 (250 mm×4.6 mm×5 µm) using mobile phase (Methanol: buffer) in the ratio of 80:20 (v/v). The run time was 7 minutes, and the wavelength for saxagliptin was taken as 230 nm. A literature review finds that there are very few HPLC techniques available using this composition of mobile phase. As a result, an attempt was undertaken to create an RP-HPLC technique for saxagliptin. The devised method was validated in terms of accuracy, precision, linearity, system suitability, LOD and LOQ, robustness, and assay. The linearity ranged from 1-3 μg/ml, with a correlation value of 0.999. The designed and validated RP-HPLC method is used to identify the eluted.
Article Details
Unique Paper ID: 165599 Publication Volume & Issue: Volume 11, Issue 1 Page(s): 1324 - 1328
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