Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

A Validated RP-HPLC Method for Estimation of Rilpivirine in Bulk and Pharmaceutical Dosage Form


Affiliations
1 Department of Pharmaceutical Chemistry, Joginpally B R Pharmacy College, Moinabad, R.R Dist., Andhra Pradesh, India
     

   Subscribe/Renew Journal


A New RP-HPLC method was developed and validated for estimation of rilpivirine hydrochloride. A simple, selective, precise, accurate and robust method was developed and validated according to the ICH guidelines for the estimation of Rilpivirine hydrochloride in bulk and tablet dosage form. The method developed is more simple, robust and accurate than the existing methods. The estimation was carried out on C18 column (150 x 4.6 mm, 5μ) using Phosphate Buffer (pH 6.0): Methanol: Acetonitrile in the ration of 40:5:55 (v/v) as mobile phase. The flow rate was 1.2 ml/min and the effluent was monitored by PDA detector at 280 nm. The retention time was 4.74 and Linearity was observed in the concentration range of 25-150 μg mL-1 with regression equation y = 34443x - 8259.4 (R<SUP>²</SUP> = 0.9997). The mean % recovery obtained is 98.6%. The percentage recovery was in good agreement with the labeled amount in the pharmaceutical formulations and the method is simple, precise, accurate and robust for the determination of rilpivirine hydrochloride in pharmaceutical formulations.

Keywords

Rilpivirine, Isocratic, New RP-HPLC and Validation
Subscription Login to verify subscription
User
Notifications
Font Size


  • http://www.drugs.com/monograph/rilpivirine-hydrochloride.html
  • Ripamonti D, Maggiolo F . Rilpivirine, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV infection. Current Opinion in Investigational Drugs 9;2008:899-912
  • Chen X, Zhan P, Li D. Recent advances in DAPYs and related analogues as HIV-1 NNRTIs. Current Medicinal Chemistry. 18; 2011:359-76.
  • Johnson BC, Pauly GT, Rai G, Patel D, Bauman JD, Baker HL, Das K, Schneider JP, Maloney DJ, Arnold E, Thomas CJ, Hughes SH . A comparison of the ability of rilpivirine (TMC278) and selected analogues to inhibit clinically relevant HIV-1 reverse transcriptase mutants. Retrovirology. 5(9);2012:99
  • Miller CD, Crain J, Tran B. Rilpivirine: a new addition to the anti-HIV-1 armamentarium. Drugs Today. 47; 2011:5-15.
  • Schafer JJ, Short WR. Rilpivirine, a novel non-nucleoside reverse transcriptase inhibitor for the management of HIV-1 infection: a systematic review. Antiviral Therapy. 17(8); 2012:495-502
  • Somsubhra G, Mithiles K, Satyabrata J, David B, Subhadip Roy. Method development and validation of Rilpivirine in bulk and pharmaceutical dosage form by using UV-Visible Spectroscopic method. Asian Journal of Research in Chemistry, 5(12); 2012:1472-1475

Abstract Views: 554

PDF Views: 2




  • A Validated RP-HPLC Method for Estimation of Rilpivirine in Bulk and Pharmaceutical Dosage Form

Abstract Views: 554  |  PDF Views: 2

Authors

Chinnalalaiah Runja
Department of Pharmaceutical Chemistry, Joginpally B R Pharmacy College, Moinabad, R.R Dist., Andhra Pradesh, India
Ravikumar Pigili
Department of Pharmaceutical Chemistry, Joginpally B R Pharmacy College, Moinabad, R.R Dist., Andhra Pradesh, India

Abstract


A New RP-HPLC method was developed and validated for estimation of rilpivirine hydrochloride. A simple, selective, precise, accurate and robust method was developed and validated according to the ICH guidelines for the estimation of Rilpivirine hydrochloride in bulk and tablet dosage form. The method developed is more simple, robust and accurate than the existing methods. The estimation was carried out on C18 column (150 x 4.6 mm, 5μ) using Phosphate Buffer (pH 6.0): Methanol: Acetonitrile in the ration of 40:5:55 (v/v) as mobile phase. The flow rate was 1.2 ml/min and the effluent was monitored by PDA detector at 280 nm. The retention time was 4.74 and Linearity was observed in the concentration range of 25-150 μg mL-1 with regression equation y = 34443x - 8259.4 (R<SUP>²</SUP> = 0.9997). The mean % recovery obtained is 98.6%. The percentage recovery was in good agreement with the labeled amount in the pharmaceutical formulations and the method is simple, precise, accurate and robust for the determination of rilpivirine hydrochloride in pharmaceutical formulations.

Keywords


Rilpivirine, Isocratic, New RP-HPLC and Validation

References