Abstract

Validated RP-HPLC Stability Indicating Method of Anti-Diabetic Active Pharmaceutical Ingredient; Saxagliptin Hydrochloride Dihydrate

Author(s): Mitali Manjrawala*, Srinivasarao V N Divvela and Rakesh Kumar

A simple and precise stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of related substances of Saxagliptin drug substance. The method was developed to separate possible degradation and process related impurities. Chromatographic condition was carried out on in Zorbax SB-C8, 150 mm x 4.6 mm, 5μm HPLC column with prepared buffer solution 1.0 ml of ortho phosphoric acid mixed with 0.1% of sodium dihydrogen phosphate solution, mix buffer solution and acetonitrile in ratio of 70:30(%v/v) used as mobile phase (a), mobile phase (b) was acetonitrile. The flow rate was set at 1.0 ml/min and the detection wavelength was 220 nm. Forced degradation study, which covered acid, base, peroxide and thermal degradation and it was performed to prove the specificity of the proposed method. The developed method has been statistically validated according to ICH guidelines and found to be simple, precise and accurate with the prescribed values. Thus the proposed stability indicating RP-HPLC method was successfully applied for the routine and stability sample analysis in quality control.

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