Development and validation of HPLC method for the assay of Etoricoxib in pharmaceutical dosage form

Abstract

Etoricoxib is a novel NSAID. It is widely used as an analgesic and anti-inflammatory drug due to its selectivity in inhibiting COX₂ so avoiding gastrointestinal tract complication resulting from using traditional NSAIDs. Due to the importance of this group in the local market and international pharmaceutical companies, this study aims to develop a novel, selective, precise, rapid and economic RP-HPLC method for the determination of Etoricoxib in bulk and tablet dosage form. The method has a run time of no longer than 3min. it was performed on column C18 with a mobile phase consisting of Methanol and Ammonium acetate with a ratio of 60:40 and pH=3.5 respectively. Using PDA detector with a wavelength of 234nm shows that the retention time of Etoricoxib is 2.7. R²=0.999 which proves that the method is linear. The recovery values percentage of the accuracy is 100.7%. The (RSD) value of precision and repeatability are less than 2% while the LOD and LOQ are (0.2, 0.7)μg/ml respectively. The selectivity results indicate no interference of excipients from the pharmaceutical formulation. The method was applied on several samples of marketed formulations from different pharmaceutical companies and the percentage of API were 100.5% – 102.3% within the acceptable limits of company A and company B respectively. This proves that the proposed method is applicable within the routine procedures of quality control laboratories and pharmaceutical companies.