Development and Validation of Uv-Spectrophotometric Method for the Determination of Atorvastatin Calcium Using Sodium Citrate as Hydrotropic Agent.

Elsaman, Tilal; Ibrahim, Enas; Adam, Mohamed E.

Simple, rapid, precise, accurate and specific UV-spectrophotometric method has been developed for atorvastatin calcium determination in bulk and in tablets dosage form. The method was based on using sodium citrate 0.01M as hydrotropic agent. Measurements of the UV absorbance were performed at 241 nm, and the developed method was validated as per ICH guidelines. The method obeyed Beer's law (R2 = 0.999) in a concentration range of 2 – 20 μg/mL. The limits of detection (LOD) and quantification (LOQ) were 0.64 and 1.9 μg/mL, respectively. At all levels of precision, RSD% values were below 2%. Accuracy of the proposed method was ascertained by standard addition method and the percentage recovery (n = 3) was within 100 – 100.43%. The method was applied to analysis of three atorvastatin tablet brands each claimed to contain 20 mg atorvastatin, and the percentage drug content was found to be 101.42 ± 1.56%, 99.04 ± 0.33%, and 97.71 ± 0.98%.

ULTRAVIOLET spectrophotometry; BEER-Lambert law; ATORVASTATIN; CITRATES; SODIUM compounds; CALCIUM; ANTILIPEMIC agents

Pharmaceutical Chemistry Journal, 2020, Vol 54, Issue 4, p422

0091-150X

Academic Journal

10.1007/s11094-020-02214-x