Development and validation of analytical methods for the estimation of drugs acting on cns in their bulk and pharmaceutical dosage forms

Abstract

quotAim: Simple, precise, accurate, robust, rapid and economical analytical methods were developed for the determination of drugs acting on CNS and its combination in pharmaceutical formulations. newlineMaterial and Methods: Various drugs acting on CNS and their combined pharmaceutical dosage forms, i.e. Dosulepin hydrochloride and Methylcobalamin, Melatonin and Pyridoxine hydrochloride and Phenytoin sodium and Phenobarbitone were selected. Analytical methods i.e. UV- spectroscopic, RP-HPLC, and stability-indicating assay method had been developed and validated according to the ICH Q2 (R1) guidelines. Also, forced degradation studies were conducted for all thee combinations. newlineResults and Discussion: Simultaneous estimation of Dosulepin hydrochloride and Methylcobalamin has been carried out by the developing the UV spectroscopic method and RP-HPLC method. Simultaneous estimation of Melatonin and Pyridoxine hydrochloride and Phenytoin sodium and Phenobarbitone has been carried out by the developing RP-HPLC method. After successful completion of method development, validation of developed methods was performed as per the ICH Q2 (R1) guidelines and the results for linearity, precision, LOD and LOQ, accuracy, robustness, system suitability study and assay of pharmaceutical dosage forms were well within the predefined acceptance criteria. Forced degradation study was performed to ensure the possible interference of degradants in the presence of active constituents for the estimation of selected drug combinations. Forced degradation studies revealed good resolution between the analytes and degradants. Interference of degradation products resulted from the stress studies was not observed for selected drugs. newlineConclusions: The proposed developed methods for selected drugs acting on CNS and their combinations were successfully validated as per ICH Q2 (R1) and from the results it was concluded that the proposed methods might be used for the routine estimation of the raw materials and in the pharmaceutical formulations. newlinequot