Stability Study of Pravastatin Under Hydrolytic Conditions Assessed by HPLC

Abstract

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.

A Review of Current Trends and Advances in Analytical Methods for Determination of Statins: Chromatography and Capillary Electrophoresis

“…Results obtained by Brain-Isasi et al [34] are somewhat different then those previously published [33]. They argue that the previously described method was to short (7 min) to observe all degradation peaks obtained by acid hydrolysis while all of them are eluting after pravastatin.…”

“…Two stability indicating studies of pravastatin under different forced degradation conditions were conducted [33,34]. Forced degradation study was performed for neutral, acid and basic hydrolysis, chemical oxidation, photochemical degradation and thermal stress using HPLC-UV [33].…”

Design of Experiments for Coating Process of Valsartan and Pravastatin Fixed-dose Combination Tablet

“…17,18 Two impurities of oxidation impurity and lactone by oxidation and lactonization were analyzed and managed by conduct of a USP pravastatin sodium tablet Related compounds (Oxidation impurity and pravastatin lactone). 10,11 We have studied to identify the concentration of opadry ® 200 in coating process according to the manufacturer's instructions.…”

Chemical Stability of Prednisone Oral Suspension and Drug Substance

“…1 In recent years, rigorous quality control processes in the pharmaceutical industry has given raise to a growing need for simple, selective and sensitive analytical methods to the study of degradation products as well as impurities; in order to assure the quality of the drug substance or drug product. 2 Glucocorticoids are widely used to treat various inflammatory and immunological diseases. 3 Prednisone (figure 1) an old drug but not least, is usually considered as oral glucocorticoid of choice for its anti-inflammatory effect, especially in asthma and allergic children diseases.…”

“…22 The objective of this work was to study and evaluate the chemical behavior of Prednisone oral suspension and drug substance using exaggerated storage conditions throughout an adequate chromatographic stability indicating method. 2,23 This study has been requested by the Analytic Control Department of a local Pharmaceutical Laboratory in order to improve the Prednisone oral suspension (Bersen®) production process and also to increase its shelf life.…”