PREFORMULATION STUDIES OF MONTELUKAST SODIUM WITH SPECIAL REFERENCE TO DEVELOPMENT OF ANALYTICAL METHODS VIA UV-VISIBLE SPECTROPHOTOMETER AND DRUG- EXCIPIENTS INTERACTION STUDIES
Abstract
The main objective of this work was to develop the preformulation studies of Montelukast Sodium. Preformulation study was mainly performed to develop simple, accurate, precise and cost effective UV-VIS Spectrophotometric method for the estimation of Montelukast Sodium, an anti asthmatic drug, in bulk and pharmaceutical dosage form. Various parameters like melting point, scanning of the drug and preparation of standard curve in different solvent systems, solubility studies and drug polymers compatibility studies were carried out. The solvent used were Distilled water, Acid buffer, pH 1.2 and Phosphate Buffer, pH 6.8 and the λmax or the absorption maxima of the drug in all these three solvent systems were found to be 349nm. The regression co-efficient obtained from the standard plots were nearly about 1.0 and which proved the linearity of the analytical methods. Calibration curves followed the linear regression. This method can be used for the determination of Montelukast Sodium in quality control of formulation without interference of the excipients. It has been seen that the drug solubility was maximum in water compare to that in Acid buffer, pH 1.2 and Phosphate Buffer, pH 6.8. The FTIR spectrum of pure drug (MLS), Pullulan, Gelatin, METHO E5P, Maltodextrin and POLYOX WSR N80 were recorded. The characteristic peaks of Montelukast sodium were compared in these spectra. As there was no shifting, deleting and broadening of the peak observed in the spectrum, it was concluded that no chemical interactions occurred.
Keywords: Montelukast Sodium, drug excipients compatibility studies and particle size distribution, UV-Vis Spectro photometry, solubility studies.