STABILITY STUDY OF PRAVASTATIN UNDER HYDROLYTIC CONDITIONS ASSESSED BY HPLC

In this work an HPLC stability-indicating method was developed and applied to study the hydrolytic behavior of pravastatin in different pHs and temperatures.From the system suitability test, the selected chromatographic conditions were a C-18 column, acetonitrile-30 mmol L -1 phosphate buffer solution pH 2 (28:72) as mobile phase, 40ºC temperature column, a flux of 1 mL/min and 239 nm as wavelength detection.The developed method exhibited an adequate repeatability and reproducibility (CV 0.11% and 0.49%, respectively) and a recovery higher than 98%.Furthermore, the detection and quantitation limits were 3.4×10 -7 mol L -1 and 3.7×10 -6 mol L -1 .The kinetic degradation of pravastatin fits to a pseudo-first order kinetic.The degradation was pH-dependent: alkaline pH < acid pH and the generation of degradation products was dependent of the media tested (one product in alkaline medium and 4 products in acid medium).Activation energy, kinetic rate constants at different temperatures, t 1/2 and t 90 values are also reported.