SEPARATION AND DETERMINATION OF
PROCESS-RELATED IMPURITIES OF
CELECOXIB IN BULK DRUGS USING
REVERSED PHASE LIQUID
CHROMATOGRAPHY
SRINIVASULU DASARI1*, SASTRY B S1, RAJENDRA PRASAD Y2,
OM PRAKASH G2
1, 2University College of Pharmaceutical Sciences, Andhra University,
Visakhapatnam -530003, India
*corresponding author: dasari.phd@gmail.com
Download Full Article

Abstract:

The present paper describes the development of a new isocratic reverse phase liquid chromatographic method for the separation and determination of celecoxib in the presence of its process-related impurities. The method was found to be simple, sensitive, precise, robust and accurate. Successful separation of the drug from the process impurities was achieved on an Inertsil ODS C18 column (250 mm X 4.6 mm, 5 μ) using phosphate
buffer (pH adjusted to 3.5): acetonitrile (45-55v/v) as eluent, at a flow rate of 1.0 mL/min and the detection wavelength was set at 250 nm. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, humidity and thermal degradation. The degradation of celecoxib was observed under oxidative environment. The method was developed and
validated with respect to specificity, system suitability, linearity, accuracy, precision, LOD (limit of detection), LOQ (limit of quantification) and robustness as per ICH (International Conference on Harmonisation) guidelines.

Top