Analytical Method Development Validation and Degradation Studies of Dosage Forms of Montelukast and Desloratadine

Abstract

The present thesis work entitled Analytical Method Development, Validation and Degradation Studies of Dosage Forms of Montelukast and Desloratadine is divided into 10 chapters as described below in brief. newlineChapter 1 describes the general introduction about causes, symptoms and treatment of allergy. Among the anti-allergic agents, the selected drugs montelukast (leukotriene receptor antagonist) and desloratadine (second generation tricyclic antihistamine) has been discussed in detail with their drug profile which is very important in method development. newlineChapter 2 give the detailed review of literature for analytical methods reported in public domain for determination of montelukast and desloratadine in bulk, formulations and different biological matrix. newlineChapter 3 is about the aim and objectives of the present work. The aim of this research is to develop and validate new analytical methods for simultaneous determination of montelukast and desloratadine in their combined dosage form and extending the application of developed method for degradation study of montelukast and desloratadine newlineChapter 4 describes the UV-Visible spectrophotometric method for simultaneous estimation of montelukast and desloratadine in tablet dosage form. The method was developed using methanol as a solvent for both the drugs owing to their high degree of solubility in methanol. The absorbance maxima for montelukast and desloratadine was found to be 344 and 238 nm respectively. Estimation of drugs from formulation was carried out by deriving simultaneous equation method. Beer s law was obeyed between 2-24 and 2-20 and#956;g/mL for montelukast and desloratadine respectively. Limit of detection values for montelukast and desloratadine were 0.310 and 0.190 and#956;g/mL respectively, while limit of quantification values were 0.940 and 0.590 and#956;g/mL for the selected drugs respectively. The method was applied for assay of drugs from marketed tablet formulation. newlineChapter 5 describes the high performance liquid chromatographic method for simultaneous estimation of th