Method Development and Validation of Assay of Rilpivirine in Rilpivirine Tablets by RP-HPLC

Shriya. N; Dr. S. Shobha Rani; Karthik. M; Dr. Y. Sridhar Reddy; Mohammad Naseeruddin1

1

Publication Date: 2024/09/10

Abstract: A method was developed and validated for determining the Assay of Rilpivirine in Rilpivirine Tablets by using WATERS HPLC 2695 with Autosampler, PDA Detector and Empower 3 Software. ACE Excel 3 C18 AR (250 x 4.6 mm, 3 μm) column was used along with a mobile phase combination Acetate Buffer: Methanol: Acetonitrile in ratio 60: 30: 10 % v/v/v. Isocratic flow with flowrate of 1.5 mL/minute, Injection volume 12 mL was employed. Column temperature of 30°C was maintained. Detection wave length of Rilpivirine was 258 nm. Run time was optimised to 5 min based on retention time. The retention time of Rilpivirine was 2.29 minutes. The method was found to be specific, linear with a square of correlation coefficient (R2 ) 1.000, accurate over the concentration range of 25 % to 200 %, precise with % RSD of six samples 1.1 and robust. Thus a simple, quick and economical method was developed and validated.

Keywords: Method Development, Validation, Assay, Rilpivirine, RP-HPLC.

DOI: https://doi.org/10.38124/ijisrt/IJISRT24SEP033

PDF: https://ijirst.demo4.arinfotech.co/assets/upload/files/IJISRT24SEP033.pdf

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