Zafirlukast

Zafirlukast, Cyclopentyl (3-(2-methoxy-4-((o-tolylsulfonyl) carbamoyl) benzyl)-1-methyl-1H-indol-5-yl) carbamate (I). A high-performance liquid chromatographic (HPLC) reversed-phase rapid resolution method has been developed and validated for estimation of zafirlukast in a pharmaceutical active pharmaceutical ingredient, which was chromatographed on reversed-phase Hypersil Gold C18 , 2.1 x 100 mm , 1.9 µ column using mixtures of acetonitrile/water and the eluents were monitored at different wavelengths. The method was validated statistically for its linearity, accuracy, robustness and precision. The method employed same chromatographic condition as above and validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and solution stability. Present work also describes the development and validation of RP- RRLC method for the determination of impurities of zafirlukast.

Both Qualitative and Quantitative analysis plays a significant role in promising the safety and therapeutic efficacy of drugs in variety dosage forms. A bioanalytical method is a set of procedures involved in the collection, processing, storage, and analysis of a biological matrix for a chemical compound. Bioanalytical studies are employed to obtain a quantitative measure of the drug or its metabolites for the study of pharmacokinetics, toxicokinetic, bioequivalence and exposure-response like pharmacokinetic/ pharmacodynamic studies. Leukotriene receptor antagonists are widely used for the treatment and management of bronchial asthma and allergic rhinitis in different dosage forms. Drugs of this class are Zafirlukast, Montelukast and Pranlukast which are being potent drugs and are more than 99% bound to plasma proteins presenting special challenges in the development and validation of analytical methods from a variety of matrices. The main objective of this review is discussion on various analytical methods used, different solvents used as mobile phase and their retention times to understand final optimized chromatographic method which could be useful for the assessment of Pharmacokinetic parameters. Among different analytical methods, HPLC, LC-MS, UV-Visible spectroscopy and spectroflourimetric techniques are the most widely preferred techniques applied by the researchers worldwide. This review article gives information about various types of extraction procedures of the drug in plasma matrices to create an optimized method for method development and to offer practical approaches for determining validation parameters like specificity, selectivity, recovery, lower limit of quantitation (LOQ), limit of detection (LOD), linearity, range, accuracy, precision, stability, ruggedness and robustness of High performance liquid chromatographic methods (HPLC)  to support pharmacokinetic studies. Accurate and sensitive analytical methods for quantitation of drugs and their metabolites are very important for the successful conduct of preclinical and clinical pharmacology studies..