Objective: The aim of this present study is to develop an accurate, precise and linear reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the estimation of Rilpivirine hydrochloride in the pharmaceutical dosage form.
Methods: The chromatographic system employs a reverse phase shim-pack C18 column, (150 x 4.6 mm; 5μ) using the mobile phase acetonitrile: (0.05M) ammonium acetate buffer, (pH -3.5 adjusted with glacial acetic acid) in the proportion of 60:40 v/v, delivered at a flow rate of 0.8 ml/min with the detection wavelength of 291 nm.
Results: The developed method resulted in retention of Rilpivirine hydrochloride at 4.5 min. Rilpivirine hydrochloride exhibited linear relationship (r2 > 0.999) over the analytical range 5-50 μg/ml. The precision is exemplified by relative standard deviation of 0.709 %. The percentage recovery was found to be in the range of 98‐102%, during accuracy studies. The limit of detection (LOD) and limit of quantitation (LOQ) was found to be 0.104 µg/ml and 0.315 µg/ml, respectively.
Conclusion: An accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of Rilpivirine hydrochloride in (25mg) tablet as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.
Key words: RP-HPLC, Method Development, Validation, Rilpivirine Hydrochloride
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