Spectrophotometric Determination of Montelukast Sodium and Levocetirizine Dihydrochloride in Tablet Dosage Form by AUC Curve Method

摘要

A simple, accurate, and precise AUC curve spectrophotometric method was developed for simultaneous determination of Montelukast sodium (MTKT) and Levocetirizine dihydrochloride (LCTZ) in combined pharmaceutical dosage forms. The principle for AUC curve method is “the area under two points on the mixture spectra is directly proportional to the concentration of the component of interest”. The area selected were 263.6 to 293.6 and 222 to 242 nm for determination of MTKT and LCTZ respectively. The two drugs follow Beer-Lambert’s law over the concentration range of 5-30 μg/ml for MTKT and LCTZ. The % estimation of the drugs was found near to 100 % representing the accuracy of the method. The recovery of the MTKT and LCTZ were found near to 100 %. Validation of the proposed methods was carried out for its accuracy, precision, specificity and ruggedness according to ICH guidelines. The proposed methods can be successfully applied in routine work for the determination of MTKT and LCTZ in combined dosage form.