SIMULTANEOUS ESTIMATION OF EMTRICETABINE, TENOFOVIR DISOPROXIL FUMARATE AND RILPIVIRINE HCL IN TABLET DOSAGE FORMS BY RP-HPLC
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 1
Abstract
ABSTRACT A simple, precise, rapid and accurate RP- HPLC method was developed for the estimation of Emtricetabine (FTC), Tenofovir Disoproxil Fumarate (TDF) and Rilpivirine HCl (RPV)in tablet dosage forms. An Inertsil ODS 3V, 250x4.6 mm, column with 5 μm particle size and the Mobile Phase- A, consisting of 0.03M KH2PO4 in water adjusting the pH-3.2 with dilute O-Phosphoric Acid, Mobile Phase-B consisting of Methanol & Water in ratio of 85:15 v/v & Acetonitrile & Buffer in ratio of 70:30 v/v, was used as diluent in the gradient mode. The flow rate was 1.5 ml/min and the effluents were monitored at 265 nm. The retention times were 6.250 min for FTC, 8.386 min for TDF and 10.296 min for RPV successively. The detector response was linear in the concentration of 80-960 µg/mL for FTC, 120-1440 µg/mL for TDF and 10-120 µg/mL for RPV. The respective linear regression equation being Y= 9474.289x + 147734.8116 for FTC, Y = 6903.437x + 202292.0234 for TDF and Y= 25680.392x + 15736.147 for RPV. The Limit of Detection (LOD) is 0.4, 0.06 and 0.5 µg for FTC, TDF and RPVrespectively. The Limit of Quantification (LOQ) is 1.2, 0.18 and 1.5 µg for FTC, TDF and RPV. The percentage assay of FTC, TDF and RPV were 98.60%, 98.68% and 99.39% respectively. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of FTC, TDF and RPV in bulk drug and in its pharmaceutical dosage forms. Keywords: Emtricetabine (FTC), Tenofovir Disoproxil Fumarate (TDF), Rilpivirine HCl (RPV), RP-HPLC, Estimation, Tablets.
Authors and Affiliations
Asadulla Khan* , Venkateswara Rao J , Ravi Pratap Pulla , Suresh Kumar Sudam , Sujana K
Keywords
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