METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING ASSAY ON GLIMEPIRIDE IN TABLET DOSAGE FORM BY RP-UFLCAbstract
The study aimed to develop a specific, exact, selective, precise and accurate Reversed-Phase Stability Indicating Ultra-fast Liquid Chromatography (RP-UFLC) strategy is created and validated for the determination of glimepiride in the tablet dosage form. The method showed an adequate separation for glimepiride from their degradation products. The optimum separation was achieved by using 250 mm × 4.6 mm C18 column (5 μm) with a mixture of potassium dihydrogen orthophosphate adjusted to pH 4.6 using (orthophosphoric acid) and acetonitrile in the ratio of 75:25 at a flow rate of 1 ml/min. The detection was carried out at 236 nm, and the retention time was found to be 5.9 min. Linearity was observed (correlation coefficient r2 0.9989). % R.S.D was found to be less than 2%. Accuracy of the method found to be in the range of 98.0 to 102.00 (% w/w). The above method was validated concerning system suitability, linearity, precision, the limit of detection (LOD) and limit of quantification (LOQ), accuracy (recovery) and robustness according to ICH guidelines. The linearity of the above methods was found to be 2-10 µg/ml for glimepiride and force degradation were carried out. Hence these methods can be used for routine analysis in quality control laboratories.
R. Maruthi * and R. S. Chandan
Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India.
09 January 2019
12 April 2019
14 August 2019
01 September 2019