A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CARBIMAZOLE API IN BULK AND FORMULATION

Abstract

The development and validation of analytical method for the determination of active pharmaceutical ingredients (API) in bulk and formulated products are critical to make sure the quality, welfare, and efficacy of pharmaceutical products. The methodical creation and exacting validation of an analytical technique for the measurement of carbimazole is the main emphasis of this study. Reverse Phase High Performance Liquid Chromatography (RP-HPLC) has produced a simple and accurate method for measuring carbimazole. A simple and precise method was developed by Reverse Phase High Performance liquid Chromatography(RP-HPLC) for determination of Carbimazole. The analytical method validation was performed within the ICH guidelines. This innovative approach also complies with regulatory requirements. Carbimazole was separated on Inertsil 8ODS (250x4.6mm, 5μ) column at a UV wavelength of 298nm. Methanol and Acetonitrile was used as a mobile phase for the determination of Carbimazole. After several trials, 80:20v/v Methanol and Acetonitrile were selected with 0.7mL/min flow rate. Following that, tests were conducted to determine whether the validation parameters such as linearity, accuracy, precision within and between days, limit of detection (LOD), and limit of quantification (LOQ) were within acceptable bounds. Carbimazole recovery and assay results fell between 98-102%, suggesting that the suggested approach can be used for carbimazole quality control analysis.