Abstract
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.
Highlights
Active antiretroviral therapy (HAART) has brought a new hope for those people who are suffering from HIV/AIDS by decreasing the death rate among people infected with HIV
The aim of this present study is to develop a precise, accurate, and linear reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the assessment of Rilpivirine hydrochloride in the pharmaceutical dosage form
Highly active antiretroviral therapy (HAART) has brought a new hope for those people who are suffering from HIV/AIDS by decreasing the death rate among people infected with HIV
Summary
Active antiretroviral therapy (HAART) has brought a new hope for those people who are suffering from HIV/AIDS by decreasing the death rate among people infected with HIV. (Fathima et al, 2018) had reported a reverse phase-high-performance LC method for the quantification of Rilpivirine hydrochloride among their degradation products by using mobile phase potassium dihydrogen phosphate (pH 3) and methanol in gradient mode. (fathima et al, 2018) Devanoboyina et al had reported an LC method for quantification of Rilpivirine hydrochloride in bulk and pharmaceutical formulations using a C18 column and mobile phase composition consisting of orthophosphoric acid buffer (pH 2.5) and acetonitrile 50:50% v/v. A recovery of 98%–102% with a simple mobile phase composition of ammonium acetate buffer (pH 3.5) and acetonitrile (40:60 v/v) in isocratic mode with shimpack C18 column This developed method is robust enough to transfer into LC-MS/MS and HR/MS characterization for the determination of Rilpivirine hydrochloride in bulk and pharmaceutical formulations. The validation of the developed RP HPLC was performed as per the ICH guidelines (Bakshi et al, 2002; ICH Q2 (R1), 2005)
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