Validated chromatographic methods for determination of some anti-hyperlipidemic used drugs

Author(s): Maha Farouk, Omar Abdel-Aziz, Reham Nagi, Laila Abdel-Fattah

The present study describes the development and subsequent validation of accurate, precise and reproducible HPLC and HPTLC methods for the analysis of Pravastatin (I), Simvastatin (II) and Ezetimibe (III) at ambient temperature. (I) was determined in presence of its acid, alkaline and oxidative- degradates, as stability-indicating study by the mentioned chromatographic techniques, utilizing acetonitrile: 0.1%acetic acid pH 3 ± 0.1 (50:50 v/v) as amobile phase and chloroform: ethanol: glacial acetic acid (9:1:0.2 v/ v/v) as a developing system.While, acetonitrile: acetic acid pH3 (60:40 v/v) and diethyl ether: chloroform(9:1 v/v) was used as a mobile phase and as a developing system for determination of (II) and (III) in presence of each other and in presence of their acid, alkaline and oxidative-degradates, respectively, by the proposed chromatographic techniques. All the proposed methods were validated according to the International Conference on Harmonization (ICH) guidelines and successfully applied to determine thementioned drugs in pure form, in laboratory prepared mixtures and in pharmaceutical preparations. The obtained results were statistically compared to the official andmanufacturer’s methods of analysis (for (I) and (II) and (III), respectively) and no significant differences were found.

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