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


Authors : Shriya. N; Dr. S. Shobha Rani; Karthik. M; Dr. Y. Sridhar Reddy; Mohammad Naseeruddin

Volume/Issue : Volume 9 - 2024, Issue 9 - September


Google Scholar : https://tinyurl.com/2p8yc5f2

Scribd : https://tinyurl.com/en97rc5b

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

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.


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.

References :

  1. Danish Sayyad, Ashok Pingle, Sarfaraz Shaikh, Shoeb Sayyed, Amol Mhaske, Tohid Sayyad. Application of Quality by Design Approach for Development and Validation of Stability Indicating RP-HPLC Method for Rilpivirine Hydrochloride in Bulk. International Journal Of Pharmacy and Pharmaceutical Research 2020, 17 (4), 473-509.
  2. Sivagami B, Sharmil Kumar. L.M, Chandrasekar. R, Niranjan Babu. M. Development and     Validation for the Simultaneous Estimation of Rilpivirine and Dolutegravir in Bulk and Pharmaceutical Dosage Forms by RP-HPLC Method. Research Journal of Pharmacy and Technology. 2022, 15 (11), 5302-6. doi: 10.52711/0974-360X.2022.00893.
  3. Patel S, Nagappan K, Santhosh GR. A new quantitative reverse phase high-performance liquid chromatographic method for the quantification of Rilpivirine hydrochloride in bulk and dosage form. Journal of Applied Pharmaceutical Science. 2018, 8 (11), 157-162. DOI: 10.7324/JAPS.2018.81122.
  4. Ismail Y, Vara Prasad M, Shaheedha S. M., Habeeb M. A New Stability Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Dolutegravir and Rilpivirine in Bulk and its Dosage Forms. Iranian Journal of Pharmaceutical Sciences. 2019, 15 (4), 53-72.
  5. Reddy BS, Harish G, Md. Ul-Haq F. Formulation and in-vitro Characterisation of Solid - Self Nanoemulsifying Drug Delivery System (SSNEDDS) of Rilpivirine. Int J Pharm Sci Res 2016, 7 (7), 3117-29.doi: 10.13040/IJPSR.0975-8232.7(7).3117-29.
  6. Reddiah. V C, Ramadevi. P, Mukkanti. K. Effective Estimation Of Rilpivirine By HPLC Method In Tablet Dosage Forms And Its In-vitro Dissolution Assessment. International Journal of Pharmacy and Pharmaceutical Science. 2012, 4 (3), 595-599.
  7. Putcharoen O, Kerr SJ, Ruxrungtham K. An update on clinical utility of rilpivirine in the management of HIV infection in treatment-naive patients. HIV AIDS Auckl. 2013, 16 (5), 231-41. doi: 10.2147/HIV.S25712.
  8. Burugula L, Pilli NR, Makula A, Lodagala DS, Kandhagatla R. Liquid chromatography-tandem mass spectrometric assay for the non-nucleoside reverse transcriptase inhibitor Rilpivirine in human plasma. Biomed. Chromatogr. (2013), 27 (2), 172–178. DOI: 10.1002/bmc.276.
  9. S. Venkatesan, N. Kannappan, Sai Sandeep Mannemala. Stability-Indicating HPLC Method for the Simultaneous Determination of HIV Tablet Containing Emtricitabine, Tenofovir Disoproxil Fumarate, and Rilpivirine Hydrochloride in Pharmaceutical Dosage Forms. Int Sch Res Notices. 2014:849149. doi: 10.1155/2014/849149.
  10. ICH Validation of Analytical Procedures: Text and Methodology Q2 (R1). International Conference on Harmonisation.

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.

Never miss an update from Papermashup

Get notified about the latest tutorials and downloads.

Subscribe by Email

Get alerts directly into your inbox after each post and stay updated.
Subscribe
OR

Subscribe by RSS

Add our RSS to your feedreader to get regular updates from us.
Subscribe