Montelukast sodium

A new simple, rapid, precise and accurate assay method was developed for simultaneous estimation of Bilastine and Montelukast in pure form and tablet form. The analytes were separated by RP HPLC on a RP-Purosnosphere C18 column (5 µm, 4.6mm* 250 mm).The mobile phase was Acetonitrile: water: methanol (30:25:45 v/v) at 1.1 ml/min flow rate satisfactorily resolve the tertiary mixture. The UV detector was operated at 214 nm for the determination of all the drugs. Linearity, accuracy and precision were found to be acceptable over the concentration ranges of 10-50 µg/ml for Bilastine and 5-25 µg/ml for Montelukast with a R2 0.9960 and 0.9974 values respectively. The optimized methods proved to be specific, robust and accurate for the quality control of drugs in bulk drug and pharmaceutical formulations.

A new, rapid, precise, selective and sensitive validative forced degradative UV spectroscopy method was developed for estimation of Montelukast sodium in bulk and pharmaceutical formulation in the developed method, the absorbance was measured at  272.19nm.the drugs obeyed the Beer’s law in the  concentration range of 30-150μg/mL. Accuracy studies of the method were determined by recovery studies and were found to be 99.9 for Montelukast sodium. It can be used for routine analysis of drug in bulk and in pharmaceutical formulation.

Aim of the present work was to formulate and evaluate an oral, time controlled drug delivery system to achieve timed release of Montelukast sodium, for the treatment of nocturnal asthma. An asthmatic attack mainly takes place early in the morning. Time controlled delivery system is capable of delivering drug when and where it is required most. Time-delayed tablets, designed to release drug after a predictable lag time, are intended for oral chronotherapy. A time dependant pulsed release system consisting of a core surrounded by coat layer of different ratios of swellable erodible hydrophilic layer HPMC K100M and rupturable hydrophobic layer Eudragit L 100 and Eudragit S 100 were prepared. These pulsatile tablets were evaluated for the drug content, thickness and in-vitro release profile, etc. and  two optimized formulation were selected and subjected to further studies. .

The present study reveals the use of Oral Thin Film (OTF) prepared by solvent casting technique. The prepared Montelukast loaded OTF can be used in emergency condition of severe asthmatic attacks. The comparison study by using Poly (ethylene) Oxide N-750 (PEO) and Hydroxy propyl methyl cellulose E15 (HPMCE15) as film forming polymer was performed. The results obtained for film disintegration and dissolution time tested orally correlated well with those obtained by the visual method. There was considerable reduction in film strength and increase in percent elongation of film with increase in glycerol content. The result showed that film containing PEO N-750 with 5 % glycerol showed better disintegration, dissolution and folding endurance when compared with film containing HPMCE15. Hence, the film containing PEO was used for further optimization where the optimized formulation (F2) depicted disintegration time of less than 6 sec, complete drug release within 8 min, percent elongation as 61.24 cm % and folding endurance more than 250 .