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Research Article

ECB. 2022; 11(5): 64-70


THE DEVELOPMENT OF A NOVEL STABILITYINDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS EVALUATION OF RILPIVIRINE AND CABOTEGRAVIR IN PURE API FORM AND TABLET DOSAGE IN ACCORDANCE WITH ICH GUIDELINES

Challamalla Pavani, Dr.V. Jayashree.




Abstract

This study's focus is on the simultaneous assessment of Rilpivirine and Cabotegravir using RP-HPLC in bulk and
tablet dosage form. Materials and methods: The separation was carried out on a Zorbax SB C18 (4.6 x 150mm, 5 m) analytical
column using a mobile phase of 40% Water (0.1 percent Formic Acid): 60% Acetonitrile. Using a UV detector, the eluents were
found at 248.0 nm. Results: Under optimal circumstances, Rilpivirine and Cabotegravir were separated at 2.084 and 3.2mins,
respectively. The detection limit for Rilpivirine was 1.02µg/mL, while the detection limit for Cabotegravir was 3.30µg/mL.
Cabotegravir had a percentage mean recovery of 100.02 percent, but Rilpivirine had a recovery rate of 100.72 percent.
Conclusion: The percentage of degradation was determined to be extremely low in each stressful environment. It was found that
optimized conditions were incredibly ideal for simultaneously determining all of them in both marketing dose form and bulk
form

Key words: Cabotegravir, Rilpivirine, method development, validation, and RP-HPLC.






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