DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ACETYLCYSTEINE AND CEFIXIME IN PHARMACEUTICAL FORMULATION

This paper describes a simple, precise, and validated high-performance liquid chromatographic method for the simultaneous quantitative determination of Acetylcysteine and Cefixime in pharmaceutical formulation in the presence of degradation products. The separation was achieved using a Kromasil C8 reverse phase column (25X 0.46mm I.D, 5µ particle size) at room temperature with an isocratic mixture of methanol:KH₂PO₄ (50mM, pH 3.0) (30:70) at a flow rate of 1ml/min and detection at 228 nm. To establish stability indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from Acetylcysteine and Cefixime. The developed method was validated as per ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The developed methodology is an economic, time-saving, straight forward and precise assay for the determination of Acetylcysteine and Cefixime in pharmaceutical preparation. It can be readily utilized for Quality Assurance (Q.A) and Research and Development (R&D) laboratories of pharmaceutical industry.