Abstract

A sensitive and validated high performance liquid chromatographic method was developed for determination of montelukast sodium S-enantiomer, A5 and A5 R-enantiomer in montelukast sodium bulk drug. Chromatographic analysis was performed on a Daicel Chiralpak^® AD-H column at 30°, the flow rate was set 0.9 ml/min, eluent was n-hexane:isopropanol:ethanol:trifluoroacetic acid:diethylamine (65:15:20:0.1:0.1, v/v/v/v/v), determination wavelength was 280 nm and the injection volume was 10 μl. The high performance liquid chromatography was validated for system suitability, precision, limit of detection and limit of quantitation, linearity, accuracy and robustness. The results indicated that the system suitability test met the requirement with resolution more than 2.0 between montelukast sodium enantiomers and greater than 6.0 between A5 enantiomers. The values of relative standard deviation were not more than 4.0% for precision test, the limit of detection from 0.11 to 0.24 μg/ml, and the limit of quantitation from 0.22 to 0.61 μg/ml, respectively. The linearity correlation coefficients (r) were greater than 0.99 for three analyses. The recovery values were ranged from 89.35 to 108.78%. The proposed method was adequate for the determination of montelukast sodium S-enantiomer, A5 and A5 R-enantiomer in montelukast sodium bulk drug.