Development and Validation of Stability Indicating RP-HPLC Method for the Simultaneous Determination of Cabotegravir and Rilpivirine in Bulk and Injection Dosage Form

A simple, sensitive, specific, accurate, and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of cabotegravir rilpivirine in injection dosage form, using a Waters Model No.2695 series compact system fitted with Agilent - C18 column (BDS) (150 X 4.6 mm, 5μm) mobile composed 0.01N KH2PO4 buffer (pH: 4.8): acetonitrile (70:30v/v). The 260 nm wavelength chosen. retention times were found to be 2.30 3.187 minutes, respectively. Linearity established range 25-150 µg/mL 37.5-225µg/mL respectively: correlation coefficient (r2) 0.9999 both drugs. Cabotegravir have %RSDs 0.4 0.3 respectively, precision. proposed methods intra- inter-day precision assessments showed relative standard deviation (%RSD) below maximum permitted level 2.0. Accuracy carried out triplicate, percentage recovery 100.25% 99.79% rilpivirine, limit detection quantification 0.24 0.74 μg/mL, respectively 1.10 3.34 Both medications put stress conditions, including thermal, acidic, basic, oxidative, photolytic stress. findings demonstrated that, exception heat, UV, neutral environments, considerable degradation oxidative conditions where good separation drug peaks seen presence products. As result, this technique can used quantitatively analyze bulk forms. Keywords: Cabotegravir, RP HPLC, Rilpivirine, ICH guidelines