Development and validation of a green RP-HPLC method for the analysis of rosuvastatin: a step towards making liquid chromatography environmentally benign

Abstract

Abstract The purpose of this study was to formulate and validate a new green high-performance liquid chromatography-ultraviolet (HPLC)-UV method for quick quantification of rosuvastatin calcium (ROC) in standard drugs. The results showed a combination of ethanol:methanol:ethyl acetate (6:3:1 v/v) at a rate of 1.0 ml/min to be the best for identifying ROC and its separation from its breakdown products. The identification of ROC was achieved using a NUCLEODUR 150 mm×4.6 mm RP C8 column packed using 5 μm filler as the stationary phase and detection was performed at 254 nm. The technique developed was checked for linearity, selectivity, accuracy, precision, robustness and sensitivity as well as specificity. The usefulness of the proposed process was confirmed by analyzing ROC in a prepared self-nanoemulsifying drug delivery system (SNEDDS) and over-the-counter products. The amount of ROC in SNEDDS was found to be 98.38%. The HPLC-UV system we developed effectively determined the ROC peak along with its breakdown products which confirmed the stability-indicating property of the projected system. The system could also be used to compare the solubility of rosuvastatin nanoparticles in standard drugs. These outcomes indicated that the developed HPLC could be effectively used for the regular investigation of ROC in standard drugs, various pharmaceutical formulations and drug release samples.