QUANTITATIVE ESTIMATION OF NIRMATRELVIR AND RITONAVIR MALEATE IN TABLET DOSAGE FORMS BY RP-HPLC METHOD
Santhosh Illendula*, Burra Vikram and Dr. Suthakaran Raj
ABSTRACT
A Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and optimized for the simultaneous estimation of Nirmatrelvir and Ritonavir in tablet dosage forms. The method was carefully developed by studying various chromatographic parameters to ensure optimal separation and accurate quantification of both drugs. The maximum absorbance for both drugs was observed at 220 nm, with excellent peak purity. A Sunfire C18 column (4.6×250 mm, 5 μm) was used to achieve good peak resolution. The flow rate was fixed at 0.9 mL/min, and the mobile phase was optimized as a mixture of Water and Acetonitrile (60:40% v/v), providing symmetrical peaks and satisfactory separation. The method demonstrated high precision, with recovery values ranging from 98.0-102% and both system and method precision found to be accurate within acceptable limits. The total run time for the analysis was 6 minutes, with Nirmatrelvir and Ritonavir eluting at 3.0 and 3.8 ± 0.02 minutes, respectively. This RP-HPLC method provides a reliable, accurate, and efficient approach for the quantitative analysis of Nirmatrelvir and Ritonavir in tablet dosage forms, suitable for routine quality control and regulatory compliance.
Keywords: Nirmatrelvir and Ritonavir, RP-HPLC, Validation, Accuracy
[Full Text Article]
[Download Certificate]
Impact Factor : 8.181 
