Abstract
An ultra-performance liquid chromatographic method for simultaneous determination of rosuvastatin and rosuvastatin degradation products was developed and optimized by using fractional factorial experimental design. Optimized method is capable to accurately determine all potential degradation products of rosuvastatin. During the optimization the effect of four chosen chromatographic factors was evaluated. The analytical method operational design region was modeled using Umetrics MODDE software and optimal chromatographic conditions were predicted. The results of the model show that the most important factors to reach good separation between the peaks of rosuvastatin impurities are the pH of buffer solution and the amount of ACN and THF in the mobile phase. The final optimized method using QbD approach was validated for linearity, accuracy and precision for determination of rosuvastatin and rosuvastatin degradation products in rosuvastatin pharmaceutical dosage forms. Limit of detection and quantification were determined for two known specified impurities. The use of experimental designs enabled us to obtain the maximum amount of information about the analytical method design region. Optimization of the method was done without additional experiments, only weighing the responses and rebuilding the statistical model. This approach is very cost-effective when evaluating a variety of different factors and their interactions.
Highlights
Rosuvastatin belongs to the statin class of pharmaceutical substances that are used for lowering of low-density lipoprotein cholesterol (LDL-C)
The optimization of a new analytical method capable of simultaneous determination of rosuvastatin assay and its degradation products in rosuvastatin drug products was performed with a single fractional factorial experimental design
11 experiments were needed for the optimization, while at least 16 experiments would be needed to cover the same analytical method operational region of the first optimization step with a traditional one factor at time (OFAT) approach
Summary
Rosuvastatin belongs to the statin class of pharmaceutical substances that are used for lowering of low-density lipoprotein cholesterol (LDL-C).Rosuvastatin is mainly administered as a calcium salt of the active hydroxy acid in tablets with 2.5, 5, 10, 20 or 40 mg of rosuvastatin (RSV). Rosuvastatin belongs to the statin class of pharmaceutical substances that are used for lowering of low-density lipoprotein cholesterol (LDL-C). Rosuvastatin substance is chemically not stable and degrades into many known and unknown degradation products under different stress conditions (thermal, oxidative, and/or photolytic)[1]. It is a white amorphous powder only sparingly soluble in water and slightly soluble in ethanol. It contains a polar methane sulphonamide group that interacts with the HMG-CoA reductase.[2,3]
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