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

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...

Full description

Saved in:
Bibliographic Details
Published in:Journal of analytical chemistry (New York, N.Y.) N.Y.), 2016, Vol.71 (1), p.126-132
Main Authors: Yegorova, A. V, Fedosenko, G. A, Scrypynets, Yu. V, Leonenko, I. I, Maltsev, G. V, Antonovich, V. P
Format: Article
Language:English
Subjects:
Analytical Chemistry
calcium
Chemistry
Chemistry and Materials Science
detection limit
high performance liquid chromatography
labor
luminescence
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:1061-9348
1608-3199
DOI:10.1134/S1061934815110040