RP-HPLC METHOD DEVELOPMENT & VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LOTEPREDNOL AND TOBRAMYCIN IN BULK & IT’S PHARMACEUTICAL DOSAGE FORM

Abstract

A simple, accurate, precise, and reliable reverse phase high-performance liquid chromatography (RP-HPLC) method was successfully developed for the simultaneous estimation of Loteprednol etabonate and Tobramycin in pharmaceutical dosage forms. The chromatographic separation was achieved using a suitable C18 column with an optimized mobile phase composition, which provided well-resolved and symmetrical peaks for both drugs within a short run time. The injection volume and run time were adjusted to ensure proper peak shape and resolution. The developed method demonstrated good linearity over the selected concentration range, with correlation coefficients close to unity, indicating a strong relationship between concentration and peak area. The precision of the method was confirmed by low %RSD values obtained from repeatability and intermediate precision studies. The accuracy study, performed through recovery experiments, showed satisfactory percentage recovery for both drugs, indicating that the method is accurate and free from interference from excipients present in the formulation. Furthermore, the method was found to be robust and specific, with no significant interference observed at the retention times of the analytes. System suitability parameters such as theoretical plates, tailing factor, and retention time were within acceptable limits, confirming the reliability of the chromatographic system. Overall, the developed RP-HPLC method is simple, rapid, economical, and suitable for routine quality control analysis of Loteprednol etabonate and Tobramycin in combined pharmaceutical formulations. This method can be effectively applied for simultaneous quantitative determination during drug analysis and quality assurance studies. SGSPS INSTITUTE OF PHARMACY, AKOLA 79