Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS DETERMINATION OF LEVOCETIRIZINE DIHYDROCHLORIDE AND MONTELUKAST SODIUM IN TABLET DOSAGE FORM

Noha S. Rashed*, Ola M. Abdallah and Noha S. Said

ABSTRACT

Four simple and accurate spectrophotometric methods have been described for the simultaneous determination of levocetirizine dihydrochloride and montelukast sodium in tablet dosage form. The first method is a bivariate calibration algorithm involving the use of two selected wavelengths 220 nm and 230 nm for the determination of studied drugs. The second method is a dual wavelength which is based on determination of levocetirizine dihydrochloride at the absorbance difference between 208 nm and 214.4 nm in which montelukast sodium absorbance difference was zero for any concentration, also montelukast sodium can be determined at absorbance difference between 355 and 390 nm in which levocetirizine dihydrochloride has absorbance zero for any concentration also. The third method is a derivative spectrophotometry, in which the two drugs were quantified using second derivative responses at 244 nm for levocetirizine dihydrochloride and at 293.2 or 335.6 nm for montelukast sodium. The fourth method is ratio difference which depends on measuring the peak amplitudes for levocetirizine dihydrochloride at 216 and 232 nm using 4 μg mL-1 montelukast sodium as a divisor, while montelukast sodium can be measured at 296.4 and 344.2 nm using 4 μg mL-1 of levocetirizine dihydrochloride as divisor. Beer’s law was obeyed in the concentration range 4–28 μg mL-1 for both drugs in all methods. The developed methods were used to determine the studied drugs in bulk powder, laboratory prepared mixtures and pharmaceutical dosage form with good accuracy and precision. All methods were validated according to ICH guidelines and the results obtained were statistically compared to those obtained from a reference method and were found to be in good agreement.

Keywords: Levocetrizine dihydrochloride, Montelukast sodium, Bivariate, Dual wavelength, Second derivative, Ratio difference.