Method Development and Validation of a Stability Indicating RP-UPLC Method For the Determination of Piroxicam in Tablet Dosage Form

Objective: A simple, novel, sensitive and rapid ultra-performance liquid chromatographic (RP-UPLC) method has been developed and validated for quantitative determination of Piroxicam (PIROX) in bulk and tablet formulations.  Method: The chromatographic development was carried out on Water C18 (3.6mm X 50 mm; 3 microns) column, with mobile phase consisting of Buffer: methanol 400ml:600 ml v\v. The flow rate was 0.6 ml/min and the effluents were monitored at 254 nm. Results: The retention time was found to be 2.876 min. The method was validated as per International Conference on Harmonization Guideline with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 25–75 μg/mL with a regression coefficient of 0.9999. The Stability indicating nature of the method was analysed by stress degradation study by acid, alkaline, oxidative, thermal condition, photolytic condition and humidity. The degradation Product of Piroxicam in Thermal Condition is characterized in LC-MS, NMR, IR and UV. The LC-MS study helped to identify the degraded product. Toxicity prediction of the thermally degraded product of Piroxicam was carried out by using OSIRIS. The method has been proved to be of high sensitivity and specificity.  Conclusion: The results of the study showed that the proposed RP-UPLC method is simple, rapid, precise and accurate which is useful for the routine determination of Piroxicam in bulk drug and in its pharmaceutical dosage form.