Pharmaceutical Dosage Form Preparation of a Synthesized Celecoxib Salt and Development of a Validated Method for its Analysis
أبو شهاب, كفاح رسمي محفوظ
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Background: Celecoxib is a non-steroidal anti-inflammatory drug (NSAID) and cyclooxygenase-2 (COX-2) inhibitor. It is used in the treatment of rheumatoid arthritis, osteoarthritis, juvenile arthritis, and acute pain. Celecoxib suffer of low systemic bioavailability due to its low water solubility. This study aimed to improve water solubility and dissolution profile by synthesizing a suitable celecoxib salt. Method: A library of celecoxib salts was synthesized, and it is water solubility was determined using UV/Visible spectrophotometric. One of the synthesized salts was chosen for tablet formulation. A simple and feasible reverse phase high performance liquid chromatography (HPLC) method was developed for the analysis of the tablet formulation. The developed method was then validated according to international guidelines. The dissolution profile, the shelf life and accelerated stability studies were performed on the formulated tablet. Results: Celecoxib-K salt showed an increase in water solubility by more than 140 folds (0.464mg/ml) compare to celecoxib. This salt was chosen to be formulated in tablet dosage form. The in vitro dissolution profile of the formulated celecoxib-K salt tablet was totally dissolved and reached plateau after 10 minutes. The developed analytical HPLC method was reliable and valid method with good linearity, accuracy and precision. Also the validated method was sensitive, the LOD and LOQ value of 0.001mg/L and 0.1mg/L respectively. The formulated celecoxib-K salt tablet was stable under room temperature and accelerated condition for 60 days. Conclusion: The solubility of celecoxib was improved by converting it to potassium salt form. The formulated tablet of celecoxib-K salt showeda good dissolution profile in water. The developed HPLC method was valid and reliable for analysis and quantification of the formulated tablet.The formulated tablet was stable at both room temperature and stress conditions.