Development of a Novel, Fast, Simple HPLC Method for Determination of Atorvastatin and its Impurities in Tablets

This paper describes the development of a novel, fast, and simple High-Performance Liquid Chromatography (HPLC) method for the simultaneous determination of atorvastatin, a widely prescribed antilipemic drug, and its related impurities in tablet formulations. The primary objective was to create a more efficient and environmentally friendly analytical procedure compared to existing methods, particularly the European Pharmacopoeia method, which is lengthy and uses toxic solvents. The researchers optimized the chromatographic conditions, employing a core-shell or superficially porous silica-based column to achieve satisfactory results for critical parameters such as peak resolution, run time, and column backpressure. The developed method significantly reduced the analysis time to less than 15 minutes, which is approximately six times faster than the official EP method. Furthermore, the method demonstrated improved sensitivity, with the limit of quantification (LOQ) being about 7 times lower and the limit of detection (LOD) about 20 times lower than the EP method, using only a 2 µL injection volume. The method was thoroughly validated according to International Conference on Harmonization (ICH) guideline Q2(R1), confirming its selectivity, linearity, accuracy, and precision. This innovative approach offers a practical and sustainable solution for routine quality control in pharmaceutical laboratories.

This paper describes the development of a novel, fast, and simple High-Performance Liquid Chromatography (HPLC) method for the simultaneous determination of atorvastatin, a widely prescribed antilipemic drug, and its related impurities in tablet formulations. The primary objective was to create a more efficient and environmentally friendly analytical procedure compared to existing methods, particularly the European Pharmacopoeia method, which is lengthy and uses toxic solvents. The researchers optimized the chromatographic conditions, employing a core-shell or superficially porous silica-based column to achieve satisfactory results for critical parameters such as peak resolution, run time, and column backpressure. The developed method significantly reduced the analysis time to less than 15 minutes, which is approximately six times faster than the official EP method. Furthermore, the method demonstrated improved sensitivity, with the limit of quantification (LOQ) being about 7 times lower and the limit of detection (LOD) about 20 times lower than the EP method, using only a 2 µL injection volume. The method was thoroughly validated according to International Conference on Harmonization (ICH) guideline Q2(R1), confirming its selectivity, linearity, accuracy, and precision. This innovative approach offers a practical and sustainable solution for routine quality control in pharmaceutical laboratories. Research Background and Significance Atorvastatin is a widely prescribed statin drug used for lowering cholesterol and preventing cardiovascular diseases. Due to its broad clinical use, stringent quality control of atorvastatin tablets is critical to ensure drug safety and efficacy. Analytical methods that accurately quantify atorvastatin and its related impurities are essenti