Development and Validation of a New RP-HPLC Method for Nirmatrelvir in Tablet Formulations and Bulk Pharmaceutical Applications

An innovative, simple, fast, and sensitive RP-HPLC method was used to identify the medication Nirmatrelvir in formulation of tablets in bulk and internally. Using water as the mobile phase (pH 5.5): 60:40 v/v acetonitrile, a good separation was achieved on HPLC. The process was verified for linearity, accuracy, precision, and specificity. Nirmatrelvir’s retention time was found to be 12.3, and the method’s linearity was suitable for values ranging from 10 to 60 μg/ml, with a correlation coefficient of 0.999. There were no alternative techniques for a single NRT medication. Although some methods were already in place, they could only be applied to Paxlovid tablets that included both Ritonavir and NRT. When the devised approach was used to in-house tablet formulation, the percentage label claim was determined to be between 99.13 and 100.44%. The lowest limits of quantification and detection for nirmatrelvir were determined to be 0.32 and 0.97 μg/ml, respectively.