Abstract

ALVAREZ BILBAO, Abeimar  and  TRUJILLO GONZALEZ, Mary. Development and validation of a stability indicating analytical HPLC method for the quantification of Rosuvastatin Calcium. Rev. colomb. cienc. quim. farm. [online]. 2014, vol.43, n.1, pp.69-85. ISSN 0034-7418.  https://doi.org/10.15446/rcciquifa.v43n1.45465.

In this work, a liquid chromatography stability-indicating method was development and validated to be applied at study the hydrolytic behavior of Rosuvastatin Calcium in different pH values and temperatures. The selected chromatographic conditions were a column C18 50 x 4.6 mm and 3.5 µm. The mobile phase was Methanol: Water-1%TFA; 25°C column temperature and flow rate 1 mL/min. The validation method exhibited an adequate repeatability and intermediate precision and a recovery higher than 98%. Furthermore, the method was lineal in range of 10 to 150 ppm. Under acidic conditions, three degradation products possible were identified as Rosuvastatin lactone, Rosuvastatin anti-isomer and Rosuvastatin lactone anti-isomer, with light were identified two major decomposition products. The validated method can be used in the stability studies and drug degradation kinetics.

Keywords : Rosuvastatin Calcium; stability-indicating method; degradation kinetic; Activation energy; Validation of methods.

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