Analytical Method Development and Validation by Using UV-visible spectrophotometry and the RP-HPLC for the Estimation of Nirmatrelvir in Bulk and Dosage form as well as Stability Indicating RP-HPLC in bulk

An antiviral medication called Nimatrelvir functions as a protease inhibitor similar to 3C. Ritonavir and nimatrelvir are combined to treat COVID-19. The rapid, simple and precise analysis methods for Nirmatrelvir are needed. In order to estimate Nirmatrelvir, we developed a UV-visible spectroscopic and RP-HPLC approach. The conditions employed for UV-visible spectroscopic include the linearity ranging from 10-60µg/ml which is the same in RP-HPLC as well. The coefficient of determination was observed which were 0.9996 and 0.9997 respectively for UV-visible spectroscopy and RP-HPLC. An Inertsil ODS 3V column (250x4.6mm, 5μ), a mobile phase consisting of a 55:45 v/v mixture of acetonitrile and water, a column oven temperature set at 25°C, a flow rate of 1.0ml/min, and a 10minute run duration in isocratic elution mode are typical RP-HPLC characteristics. The forced degradation tests in powdered and solutions form were carried out. The drug showed specificity as there was no interference of impurities in the estimation of Nirmatrelvir. The peak purity of Nirmatrelvir was then assessed by using a high-performance liquid chromatography photodiode array detector (PDA) on all degradation samples. The developed approach was determined to be a straightforward, innovative, methodical, and economic stability-indicating approach after it underwent complete validation in line with ICH (International Council of Harmonisation) principles.