ARP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF NIRMATRELVIR AND RITONAVIR IN TABLET FORMULATION

P. V. Balaji, Shaik Nabi Rasool*, G. Bhargav, K. Mangamma

For the quantitative measurement of Ritonavir and Nirmatrelvir in pharmaceutical dosage form, an easy quick, accurate, sensitive, and repeatable reverse phase high performance liquid chromatography approach has been devised. Ritonavir and Nirmatrelvir were separated chromatographically using a Waters Alliance-e2695 using a Luna Phenyl Hexyl column and a mobile phase that contained 40:60% v/v acetonitrile:ammonium acetate pH-3.0/OPA. A photodiode array detector operating at room temperature was used to measure the 1.0 ml/min flow rate by absorption at 266 nm. For Ritonavir and Nirmatrelvir, the number of theoretical plates and tailing factors were NLT 2000 and should not exceed 2, respectively. Every measurement's relative standard deviation of peak areas is consistently smaller than 2.0. ICH principles were followed in the validation of the suggested approach. For the quantitative analysis of Ritonavir and the stability research of Nirmatrelvir, the approach was determined to be straightforward, affordable, appropriate, exact, accurate, and reliable.