DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF MONTELUKAST SODIUM, LEVOCETIRIZINE DIHYDROCHLORIDE AND ACEBROPHYLLINE IN FIXED-DOSE COMBINATION TABLETS

A fixed-dose combination of montelukast sodium, levocetirizine dihydrochloride, and acebrophyl line is used in the treatment of asthma, COPD, allergic rhinitis and other conditions where patients feel difficulty in breathing. The present study was designed to develop and validate a simple, sensitive, precise and accurate isocratic reverse-phase high-performance liquid chromatography (HPLC) method for simultaneous estimation of montelukast sodium (MTKT), levocetrizine dihydrochloride (LTZ) and acebrophyl line (ABP) in fixed-dose combination tablets. Chromatographic separation of these drugs was achieved on Hypersil ODS C18 column (250 × 4.6 mm, 5µm) as stationary phase. A mixture of methanol, acetonitrile and 20 mM ammonium acetate buffer in the ratio of 60:30: 10v/v was used as the mobile phase at a flow rate of 0.8 ml/min with detection at 232 nm at a column temperature set at 35 ℃. The total elution time for the three drugs was about 10 min. The developed method was validated by conducting system suitability, selectivity, linearity, precision, accuracy, limits of detection, and limits of quantification as per ICH guidelines. The method was accurate with assay values of 99.89% w/w for LTZ, 100.30% w/w for ABP and 100.59%w/w for MTKT, precise with intra-day and inter-day % RSD less than 2% and robust with % RSD less than 2% for the three drugs. The developed method can be applied to simultaneously quantify fixed-dose combination products containing LTZ, ABP and MTKT.