Ashour Safwan, Nakshbandi Husni, Omar Soulafa
Department of Chemistry, Faculty of Sciences, University of Aleppo, Aleppo, Syria.
Int J Biomed Sci. 2008 Jun;4(2):135-9.
A simple, sensitive and precise high-performance liquid chromatographic formulations assay for pravastatin (PVS) is described. Good chromatographic separation was achieved using a Teknokroma C8 (5 μm, 25cm × 4.6mm) column and a mobile phase consisting of 10mM ammonium acetate: methanol: triethylamine (40:60:0.17 v/v/v) while at a flow-rate of 1.0 mL min(-1). PVS was detected at 239 nm and was eluted 2.15 min after injection. No endogenous substances were found to interfere. No internal standard was required. Linearity range for PVS was 0.4-1000 μg mL(-1). The determination of intra- and inter-day precision (RSD) was less than 2.94 and 2.97%, at all concentration levels. Statistical treatment of the experimental results indicates that the method is precise and accurate. The proposed method was applied to the determination of the component in commercial tablets with no interference from the excipients. A comparative study between the suggested procedure and the pharmacopoeial method for this compound in the tablets showed no significant difference between the two methods.
描述了一种用于普伐他汀（PVS）的简单、灵敏且精确的高效液相色谱制剂分析方法。使用Teknokroma C8（5μm，25cm×4.6mm）色谱柱和由10mM醋酸铵：甲醇：三乙胺（40:60:0.17 v/v/v）组成的流动相，流速为1.0 mL min(-1)时，实现了良好的色谱分离。PVS在239nm处检测，进样后2.15min洗脱。未发现内源性物质干扰。无需内标。PVS的线性范围为0.4 - 1000μg mL(-1)。在所有浓度水平下，日内和日间精密度（RSD）的测定均小于2.94%和2.97%。实验结果的统计处理表明该方法精确且准确。所提出的方法应用于市售片剂中成分的测定，无辅料干扰。该建议方法与片剂中该化合物的药典方法之间的比较研究表明，两种方法之间无显著差异。
