RP-HPLC Method Development and Validation for Simultaneous Estimation of Tenofovir Disoproxil Fumarate and Emtricitabine in Pharmaceutical Dosage Form

Abstract

Objective: A reverse- phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for estimation of combined formulation containing tenofovir(disoproxilfumarate) (TDF) and emtricitabine (EMT). Method: Chromatographic separation was performed on RP-C18 column. The optimized mobile phase of composition (Methanol: Water and pH adjusted to 3.8 with acetic acid was pumped withflow rate of 0.8ml/min in the 70:30% v/v) ratio and the eluents were monitored at 261nm. Results: The assay was performed with tablet and percentage of assay was found to 99.91% for TDF and 99.69% for EMT respectively. Linearity was obtained in the concentration range of 2-12µg/ml for TDF and 2-12µg/ml for EMT. The method was statistically validated and RSD was found to be <2%, indicating high degree of accuracy and precision of the proposed RP-HPLC method. Conclusion: The method suggests usefulness of unique mobile phase during the estimation of combination of dosage forms. Due to its simplicity, rapidness, high precision and accuracy, the proposed RP-HPLC method can be applied for simultaneous determination of TDF and EMT in pharmaceutical dosage form.