A New RP-HPLC Method for Quantitative Analysis of Atorvastatin Calcium in Bulk and Pharmaceutical Dosage form by Using Design of Experiment Technique Optimization
Elsadig H. Rudwan *
Amipharma Laboratories Ltd., Khartoum, Sudan
Amna B. W. E Mohammed
College of Animal Production Science and Technology, Sudan University, Sudan
Ahmed E. M. Saeed
Department of Chemistry, College of Science, Sudan University of Science and Technology, Sudan
*Author to whom correspondence should be addressed.
Abstract
A rapid high-performance liquid chromatography method was developed and validated for the determination of atorvastatin calcium in pharmaceutical dosage forms, and for evaluation of its stability in stress testing. Separation of atorvastatin was successfully achieved on a C-18 column utilizing -acetonitrile, Phosphate buffer pH 3.0 at the volumetric ratio of 59:41. The detection wavelength was 245 nm. The method was validated and the response was found to be linear in the drug concentration range of 6.4 µg/mL – 9.6 µg/mL. The correlation coefficient was 0.9999. The RSD values for precision as repeatability and reproducibility were 0.377 and 0.70 respectively, and the regression equation was Y= 0.9962x+0.2241. All the validation parameters were within the acceptable range. The developed method was successfully applied to estimate the amount of atorvastatin calcium in tablets.
Keywords: DOE, validation, RP-HPLC, atorvastatin calcium