Krol G J, Beck G W, Ritter W, Lettieri J T
Miles Inc., West Haven, CT 06516.
J Pharm Biomed Anal. 1993 Nov-Dec;11(11-12):1269-75. doi: 10.1016/0731-7085(93)80113-f.
An LC procedure suitable for quantitative analysis of pg ml-1 concentrations of the HMG-CoA reductase inhibitor rivastatin in blood plasma was developed. The procedure involves an extraction step, chromatography on an ODS column, and fluorometric detection of a post-column photolytic decomposition product that was isolated and identified. The achieved quantitation limit (25 pg ml-1) facilitated analysis of relatively low rivastatin concentrations in plasma that were observed after 100-300 micrograms oral doses of rivastatin. At 25 pg ml-1 concentration the RSD ranged from 3.6 to 13.5% and mean deviation from the nominal value was 8.0%; at 8 ng ml-1 the RSD range was 0.7-3.6% while the mean deviation was -1.8%. The concentrations obtained with the LC procedure were compared to the concentrations obtained with a specific but less sensitive capillary GC method and a radioimmunoassay (RIA) procedure. Concentrations obtained with the HPLC and GC procedures agreed within experimental error; the RIA concentrations were about 30% higher.
开发了一种适用于定量分析血浆中pg ml-1浓度的HMG-CoA还原酶抑制剂利伐他汀的液相色谱法。该方法包括萃取步骤、在ODS柱上进行色谱分析以及对分离和鉴定出的柱后光解分解产物进行荧光检测。所达到的定量限(25 pg ml-1)有助于分析口服100 - 300微克利伐他汀后血浆中相对较低的利伐他汀浓度。在25 pg ml-1浓度下,相对标准偏差(RSD)范围为3.6%至13.5%,与标称值的平均偏差为8.0%;在8 ng ml-1时,RSD范围为0.7%至3.6%,平均偏差为-1.8%。将液相色谱法获得的浓度与用一种特定但灵敏度较低的毛细管气相色谱法和放射免疫分析(RIA)方法获得的浓度进行比较。高效液相色谱法和气相色谱法获得的浓度在实验误差范围内一致;放射免疫分析的浓度约高30%。