DEVELOPMENT OF SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF ATORVASTATIN IN TABLETS
DOI:
https://doi.org/10.11603/mcch.2410-681X.2021.i4.12745Keywords:
spectrophotometry, atorvastatin, determination, validation, analytical eco-scaleAbstract
Introduction. Atorvastatin is widely represented in the pharmaceutical market of Ukraine hypolipidemic agent for the treatment of hyperlipidemia and prevention of cardiovascular system diseases. Many procedures are known for assay of atorvastatin, however, many of them have limitations due to the using of harmful reagents, time consuming, heating, extraction etc.
The aim of the study – to develop simple, cost-effective, UV-spectrophotometric method for the estimation of atorvastatin in tablet dosage form that are available on the Ukrainian market according to the principles of "green" chemistry.
Research Methods. The studies were carried out on Shimadzu UV-1800 spectrophotometer (Japan), electronic laboratory balance RAD WAG AS 200/C, ultrasonic bath Sonorex Digitec DT100H, measuring glassware class A. Atorvastatin calcium salt trihydrate CRS (Sigma-Aldrich ≥98 %, HPLC), methanol R (Honeywell Riedel-de Haen™, 99.9 %), Atorvastatin-Teva tablets, 10 mg No.10 (Teva, Israel), batch No.19939.
Results and Discussion. For the development of determination procedure of atorvastatin by direct UV spectrophotometry, an intensely expressed absorbance maximum of the latter at 247 nm was selected. Correctness of the analytical procedure was confirmed by calculating its complete uncertainty (2.56 %). The linear dependence in the range of 8–40 mg/ml was obtained. The specificity of the method is proved by the absence of absorbance at the analytical wavelength in solutions of placebo tablets. The precision of the experimental data was characterized by a low standard deviation in the studied concentration range of API and the systematic error was 0.02 %. In robustness studies it was found the stability of solution absorbance over time for 100 minutes. According to the analytical eco-scale, the method belongs to the “Excellent green analysis”.
Conclusion. A method for UV spectrophotometric determination of atorvastatin in tablets (λmax = 247 nm) was developed. The complete uncertainty of the developed method was calculated. According to such validation parameters as linearity, precision, accuracy and robustness, the method is correct.
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