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 :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.