DEVELOPMENT AND VALIDATION OF THE HS-GC-FID METHOD FOR THE QUANTIFICATION OF RESIDUAL SOLVENTS IN DESLORATADINE

Abstract

Testing for residual solvents is a crucial component of both reference material certification and pharmaceutical quality control. Developing and validating a head space-gas chromatography method for measuring residual solvents in desloratadine in pharmaceutical dosage forms was the aim of the current investigation. To create desloratadine, an active ingredient in pharmaceuticals, the pharmaceutical industry commonly uses organic solvents such as methanol, diethyl ether, dichloromethane, and tetrahydrofuran. A novel technique for measuring residual solvents in desloratadine was created using a flame ionization detector and headspace gas chromatography. HP1 Column (30m×0.53mm, 1.8µm), intake port maintained at 250°C, detector temperature 260°C, oven temperature 190°C, and injection volume 1µl with 1:50 split ratio utilizing nitrogen as a carrier gas at a flow rate of 1ml/min were the optimum chromatographic conditions. Using criteria from the International Conference on Harmonization, the method's linearity, range, detection limit, quantitation limit, accuracy, precision, specificity, system appropriateness, and robustness were all validated. It was determined that the idea was appropriate for determining four distinct residual solvents. The approach is particular, linear, exact, accurate, and sensitive, according to validation data, where recoveries varied from 90 to 110 percent. This thoroughly tested technique has been used to identify any remaining solvents in actual desloratadine bulk samples.