Determination of residual amounts of Rosuvastatin Calcium on the surfaces of pharmaceutical equipment by HPLC and luminescence

Abstract

Highly sensitive procedures are proposed for the chromatographic (high-performance liquid chromatography, HPLC) and luminescence determination of trace amounts of Rosuvastatin Calcium in washings after the cleanup of pharmaceutical equipment. The developed procedures are validated for the following parameters: specificity, linearity, accuracy, detection limit, and quantification limit. The calibration curves are presented in the concentration range 0.01–1.0 µg/mL (HPLC) and 0.1–10.0 µg/mL (luminescence); the detection limits are 0.005 and 0.032 µg/mL, respectively. The efficiency of the sampling method is over 90%. It is found that the difference in the results of analysis of samples by two procedures is statistically insignificant. The luminescence procedure compared to HPLC has several advantages, i.e., lesser labor intensity, rapidity, and lesser reagent consumption; but the HPLC procedure is an order of magnitude more sensitive.