DEVELOPMENT AND VALIDATION OF AN UPLC METHOD FOR IN-VITRO STUDY OF GLIPIZIDE EXTENDED RELEASE TABLETSAbstract
A Reversed Phase Ultra Performance Liquid Chromatographic (RP-UPLC) method was developed for the determination of glipizide (GLI) in in-vitro study during formulation development. The chromatographic separation was achieved on a Acquity UPLC BEH C18 (50 mm × 2.1 mm, 1.7 µm) column, with a mixture of 55 volumes of methanol and 45 volumes of buffer contain 0.001M sodium dihydrogen phosphate in isocratic elution with flow rate of 0.3 mL/min. The eluted compound was monitored at a wavelength of 276 nm using a UV detector. The method described herein separated glipizide and glipizide related compound-A from all other formulation components within a run time of 1.2 min. The RP-HPLC method was developed and validated according to the International Conference on Harmonization (ICH) guidelines. This method was successfully applied in the quantitative determination of glipizide in in-vitro study during formulation development. The procedure described herein is simple, selective, and reliable for routine quality control analysis as well as stability testing.
Harshal Kanubhai Trivedi*, Nayan Kshtri, Vipul Patel and Vinay Roa
Analytical Research Lab, Cadila Pharmaceutical Ltd, Dholka-387 810, Gujarat, India
18 May, 2012
11 August, 2012
27 August, 2012
01 September, 2012