DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHIC METHOD FOR ESTIMATION OF RILPIVIRINE AND ITS APPLICATION IN SOLUBILITY ENHANCEMENT STUDIES
Kanchan Chauhan* and Saloni Abdul Shikur Shaikh
ABSTRACT
Aim of the present study is to develop a precise, accurate and linear RP-HPLC method for the assessment of rilpivirine. The chromatographic system employs Inertsil C18 column using mobile phase Acetonitrile: phosphate buffer in the ratio of 80:20 v/v, at a flow rate of 1 ml/min with the detection wavelength of 280 nm. The retention time of rilpivirine was found to be 4.16 minutes. Rilpivirine exhibited a linear relationship (r2 > 0.9997) over the analytical range of 10–50 μg/ml. The percentage recovery was observed in the range of 99.00% to 99.96%, indicating the accuracy of the study. The detection limit and quantification limit were found to be 1.52 μg/ml and 4.61 μg/ml respectively stating method is sensitive. Relative standard deviation of the test results of the selected parameters at different condition was calculated and found within the ICH limit indicating that the method is sufficiently robust. Further the extension of the developed and validated method was successfully carried out for identification and quantification of rilpivirine solid dispersion.
Keywords: Rilpivirine, RP-HPLC, Method Development and Validation.
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