Development and validation of RP-HPLC method for simultaneous estimation of docetaxel and ritonavir in PLGA...

The main objective of the present study was to develop and validate simple, precise, sensitive and accurate RP-HPLC method for the simultaneous estimation of docetaxel (DTX) and ritonavir (RTV) in PLGA nanoparticles (PLGA-NPs).

The DTX and RTV co-loaded PLGA-NPs were developed by the nanoprecipitation technique. The RP-HPLC method was developed by using (Agilent Compact LC-1220) and Zorbax Eclipse plus C18 column (150×4.6mm, 3.5μm, Agilent). Finally, the developed method was validated according to the international conference on harmonization (ICH) guidelines.

The chromatographic separations of DTX and RTV with good resolutions have been achieved by using the mobile phase Acetonitrile: Water (60:40 v/v) containing 0.1% v/v of orthophosphoric acid at a flow rate of 1.0mL/min, injection volume of 25μL, and at 239nm wavelengths. The validated method found to be linear in the range of 0.001-100μg/mL for DTX and RTV. Detection and quantification limits for DTX were found to be 0.7 and 2.31μg/mL respectively and for RTV it is 0.3 and 2.87μg/mL respectively. The % RSD was found to be less than 2% revealing the precision of the developed method. Besides, the recovery rate was observed close to 100% for both the drugs confirming the accuracy of the method. Minor alterations in the chromatographic conditions have revealed robustness and ruggedness of the developed method.

The developed analytical method is simple, precise, sensitive, and reproducible which can be used for the simultaneous estimation of DTX and RTV in the PLGA-NPs.