Simultaneous Determination of Nirmatrelvir and Ritonavir in Bulk and Tablet Dosage Form by RP-HPLC Method

Aim

A Rational and time-efficient, as well as, selective and gentle approach based on simultaneous estimation to the RP-HPLC verification in compliance with the most recent requirements for nirmatrelvir and ritonavir.

Materials and Methods

In the process of developing and validating a easy and efficient RP-HPLC method that adheres to the Q2R1 guideline of the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, several factors such as linearity, precision, limit of detection, limit of quantification, and accuracy have been considered. For data collected from different aliquot runs for Agilent Tech, statistical data analysis was done. Gradient System: Auto sampler, UV (DAD) detector installed.

Results

The analysis of medications and degradants was done with 20 µL injection loop at the wavelength of 234 nm, using a reverse phase C18 Agilent column with dimensions 4.6×250 mm, 5 µm particle size, and software Chemstation 10.1. Acetonitrile and 0.1% OPA buffer in the ratio of 41:59 volume per volume at room temperature and the flow According to the outcomes of the study, the LOD and the LOQ were displayed within limit as described by ICH.

Conclusion

The devised approach is quick, simple, accurate, precise, economical, and selective for the confirmation test, according to the validation experiments. Therefore, the aforementioned approach is straightforward and frequently used to determine the levels of ritonavir and nirmatrelvir in tablet dosage forms.