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Quality by Design (Qbd) Approach to Develop HPLC Method for Estimation of Gliclazide and its Impurity (Gliclazide Impurity A) in Bulk Drug

Author(s):

Surendran Vijayaraj*, Narahari N Palei and Thummala Katyayani   Pages 1 - 8 ( 8 )

Abstract:


Background: Gliclazide Impurity A (GI-A) is one of the gliclazide impurities, as described in the European Pharmacopoeia. Objective: The objective of this study was to develop and validate simple, robust and accurate reversephase high-performance liquid chromatography (RP-HPLC) method for estimation of gliclazide along with GI-A in bulk by optimising chromatographic parameters using Box Behnken design in response surface methodology. Method & Results: Box Behnken design was employed for optimizing flow rate, injection volume and strength of the buffer in order to minimize retention time of both gliclazide and GI-A. The optimized strength of orthophosphoric acid buffer in a mixture of Acetonitrile (50:50 v/v), flow rate and injection volume were found to be 25mM, 1mL/min, 20

Keywords:

Gliclazide, Impurity A, RP-HPLC, Box Behnken design, QbD

Affiliation:

Sree Vidyanikethan College of Pharmacy, Department of Pharmaceutical Analysis, Sree Vidyanikethan College of Pharmacy, Department of Pharmaceutics, Sree Vidyanikethan College of Pharmacy, Department of Pharmaceutical Analysis



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