Method development and validation for simultaneous estimation of nirmatrelvir and ritonavir by using rp hplc

Abstract

For the simultaneous estimate of nimatrelvir and ritonavir in a pharmaceutical dose form, a straightforward, precise, and accurate approach was created. Using a typical Agilent C18 column (150 x 4.6 mm, 5), the chromatogram was conducted. The mobile phase was pumped through the column at a flow rate of 0.8 ml/min, comprising a 60:40 ratio of Acetonitrile to Buffer 0.01N KH2PO4 (2.2 pH). This approach employed 0.01N KH2PO4 as a buffer. The 30-degree Celsius mark was kept constant. The chosen optimum wavelength was 265 nm. Ritonavir and Nirmatrelvir were shown to have retention times of 2.816 and 2.241 minutes, respectively. It was discovered that Ritonavir and Nirmatrelvir had percentage RSDs of 0.6% and 0.4%, respectively. 99.15% and 99.77% of the patients recovered from nirmatrelvir and ritanavir, respectively. Regression models for Nirmatrelvir and Ritonavir yielded LOD and LOQ values of 0.21 and 0.16 and 0.65 and 0.48, respectively. Nirmatrelvir's regression equation is y = 16802x + 995.5, while Ritonavir's is y = 16802x + 995.5. The devised method was found to be straightforward and cost-effective due to the reduction of both the retention times and run time. Industries can use this approach for routine quality control testing.