A STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LORNOXICAM, PARACETMOL AND SERRATIOPEPTIDASE IN COMBINED FORMULATION

For routine analytical purpose it is desirable to establish methods capable of analyzing huge number of samples in a short time period with good robustness, accuracy and precision without any prior separation step. HPLC method generates large amount of quality data, which serve as highly powerful and convenient analytical tool. Lornoxicam & Paracetamol was freely soluble in water and alcohol. Serratiopeptidase was freely soluble in alcohol and sparingly soluble in water. Methanol and potassium & hydrogen ortho phosphate (pH 3) was chosen as the mobile phase. The run time of the HPLC procedure was 10 minutes. The method was validated for system suitability, linearity, precision, accuracy, specificity, ruggedness robustness, LOD and LOQ.The system suitability parameters were within limit, hence it was concluded that the system was suitable to perform the assay he method shows linearity between the concentration range of 10-100 mu g/ml. The % recovery of Lornoxicam, Paracetamol and Serratiopeptidase were found to be in the range of 99.22 % - 100.11 %. As there was no interference due to excipients and mobile phase, the method was found to be specific. The method was robust and rugged as observed from insignificant variation in the results of analysis by changes in Flow rate and Mobile phase composition separately and analysis being performed in different analysis. Good agreement was seen in the assay results of Pharmaceutical formulation by developed method. Hence it be concluded that the proposed method was a good approach for obtaining reliable results and found to be suitable for the suture analysis of Lornoxicam, Paracetamol and Serratiopeptidase in Bulk drug and Pharmaceutical formulation.