STABILITY INDICATING UV SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF MONTELUKAST SODIUM AND THEOPHYLLINE IN COMBINED PHARMACEUTICAL FORMULATION

Abstract

The scope of developing and validating a method is to ensure a suitable strategy for particular analysis which is more specific, accurate and precise. Here the main focus is on stability of drug. To develop and validate an accurate, precise, reliable and cost-effective stability indicating UV method for simultaneous estimation of Montelukast Sodium and Theophylline in combined pharmaceutical formulation. Montelukast sodium is used as antihistaminic and Theophylline is used as anti-asthmatic. The wavelength of maximum absorbance for Montelukast Sodium and Theophylline was 344nm and 273nm respectively. The UV method used for analysis was Q-Absorption ratio method, overlain spectra shows the isoabsorptive point at 255nm.The linear regression analysis data for the calibration plots showed good linear relationship with R²=0.9999 and 0.9999 for Montelukast Sodium and Theophylline respectively at the concentration range of 4-40 µg/ml for Montelukast sodium and 4-28 µg/ml for Theophylline. The method was validated for accuracy, precision, specificity and robustness. The proposed developed stability indicating method can be applied for identification and quantitative determination of Montelukast sodium and Theophylline in bulk and drug formulation.