Development and Validation of High Performance Liquid Chromatography Method for Determination Atorvastatin in Tablet

International Conference on Advanced Materials for Better Future 2017

Yugatama, A.^1 ; Rohmani, S.^1 ; Dewangga, A.^1

Department of Pharmacy, Faculty of Mathematics and Natural Sciences, Sebelas Maret University, Indonesia^1

关键词: Analytical method;    Development method;    Limit of detection;    Limit of quantitations;    Linearity range;    Methanol-water;    Pharmaceutical industry;    Reverse phase;   

Others  :  https://iopscience.iop.org/article/10.1088/1757-899X/333/1/012081/pdf
DOI  :  10.1088/1757-899X/333/1/012081

来源: IOP

【 摘 要 】

Atorvastatin is the primary choice for dyslipidemia treatment. Due to patent expiration of atorvastatin, the pharmaceutical industry makes copy of the drug. Therefore, the development methods for tablet quality tests involving atorvastatin concentration on tablets needs to be performed. The purpose of this research was to develop and validate the simple atorvastatin tablet analytical method by HPLC. HPLC system used in this experiment consisted of column Cosmosil C18 (150 x 4,6 mm, 5 μm) as the stationary reverse phase chomatography, a mixture of methanol-water at pH 3 (80:20 v/v) as the mobile phase, flow rate of 1 mL/min, and UV detector at wavelength of 245 nm. Validation methods were including: selectivity, linearity, accuracy, precision, limit of detection (LOD), and limit of quantitation (LOQ). The results of this study indicate that the developed method had good validation including selectivity, linearity, accuracy, precision, LOD, and LOQ for analysis of atorvastatin tablet content. LOD and LOQ were 0.2 and 0.7 ng/mL, and the linearity range were 20 - 120 ng/mL.