Abstract

DESIGN, CHARACTERIZATION AND IMPURITY PROFILING OF CELECOXIB BY RP-HPLC

Rajkumar Prava*, Ganapathy Seru, Sabbella Radha Krishna and Surendra Babu Lagu

ABSTRACT

Celecoxib is one of the most widely used drug around the world. There are various pharmacological activities reported for the wonder moiety. Celecoxib is a non-steroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain and primary dysmenorrhoea. The most common side effects upon usage of Celecoxib include indigestion, diarrhoea and abdominal pain. Celecoxib produces its therapeutic effects by inhibiting cyclooxygenase (COX), an enzyme which is responsible for the production of prostaglandins. Celecoxib, in addition has other pharmacological activities that are entirely independent of its COX-2 inhibitory activity. This selectivity allows Celecoxib and other COX-2 inhibitors to reduce inflammation (and pain) while minimizing gastrointestinal adverse drug reactions (e.g. stomach ulcers) that are common with non-selective NSAIDs. The present study is based on the synthesis and impurity profiling. A new isocratic RP-HPLC method was developed for the separation and determination of process related impurities in Celecoxib and validated as per ICH guidelines. The method was found to be simple, sensitive, precise, robust and accurate. Therefore, this method can be used for routine testing as well as stability analysis of Celecoxib drug substance. All statistical results (Mean, % RSD and % recovery) were within the acceptance criteria.

Keywords: Celecoxib, pharmacological activity, chromatographic techniques, impurity profile.