Analytical Method Development and Validation for Simultaneous Quantification of Levodropropizine and Chlorpheniramine Maleate in Bulk and Pharmaceutical Formulation by Rp-HPLC

Abstract

A high performance liquid chromatographic assay method was developed for the simultaneous estimation of Levodropropizine and Chlorpheniramine maleate in syrup dosage form. Chromatogram was run through Discovery C18 (4.6 x 150mm, 5µm) column. Mobile phase containing 0.01N KH2PO4 buffer (p H 2.8): acetonitrile (50:50) pumped through the column at a flow rate of 1.0 ml/min. The column temperature was maintained at 30°C and the detector was monitored at a wavelength of 215 nm. The injection volume was 10 µl with a total run time of 7 min. Retention time of Levodropropizine and Chlorpheniramine maleate were found to be 2.451 min and 3.595 min. The calibration curves were linear in the concentration range of 15-90 µg/ml and 1-6 µg/ml of Levodropropizine and Chlorpheniramine maleate respectively (r 2 = 0.999). The percentage recoveries were found to be 99.26 % for Levodropropizine and 99.43 % for Chlorpheniramine maleate. The limit of detection was found to be 0.33 μg/ml & 0.03 μg/ml and limit of quantitation was found to be 1.00 μg/ml & 0.09 μg/ml for Levodropropizine and Chlorpheniramine maleate respectively. The most effective RP-HPLC method was developed for the estimation of syrup dosage form containing Levodropropizine and Chlorpheniramine maleate. The developed method was validated for system suitability, specificity, accuracy, precision, linearity, limit of detection, limit of quantitation and robustness according to International Conference on Harmonization (ICH) guidelines.

Analytical Method Development and Validation for Simultaneous Quantification of Levodropropizine and Chlorpheniramine Maleate in Bulk and Pharmaceutical Formulation by Rp-HPLC

“…The developed method was validated for parameters such as system suitability, specificity, linearity, accuracy, precision, LOD, LOQ and robustness according to ICH guidelines for analytical procedures Q2 [R1]. 10 System suitability To verify the system performance, six replicate samples containing 600 µg/ml of Levodropropizine and 40 µg/ml of Chlorpheniramine maleate were analyzed using the developed method. The factors such as theoretical plate count, tailing factor and resolution between the peaks were taken into consideration for testing system suitability.…”