Bahrami Gholamreza, Mohammadi Bahareh, Mirzaeei Shahla, Kiani Amir
Medical Biology Research Center, Medical School, Karmanshah University of Medical Sciences, Kermanshah 6714869914, Iran; School of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran.
J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Nov 5;826(1-2):41-5. doi: 10.1016/j.jchromb.2005.08.008. Epub 2005 Sep 16.
A rapid and sensitive high-performance liquid chromatographic method was validated and described for determination of atorvastatin in human serum. Following liquid-liquid extraction of the drug and an internal standard (sodium diclofenac), chromatographic separation was accomplished using C18 analytical column with a mobile phase consisting of sodium phosphate buffer (0.05 M, pH 4.0) and methanol (33:67, v/v). Atorvastatin and the internal standard were detected by ultraviolet absorbance at 247 nm. The average recoveries of the drug and internal standard were 95 and 80%, respectively. The lower limits of detection and quantification were 1 and 4 ng/ml, respectively, and the calibration curves were linear over a concentration range of 4-256 ng/ml of atorvastatin in human serum. The analysis performance was studied and the method was applied in a randomized cross-over bioequivalence study of two different atorvastatin preparations in 12 healthy volunteers.
验证并描述了一种快速灵敏的高效液相色谱法，用于测定人血清中的阿托伐他汀。在对药物和内标（双氯芬酸钠）进行液-液萃取后，使用C18分析柱进行色谱分离，流动相由磷酸钠缓冲液（0.05 M，pH 4.0）和甲醇（33:67，v/v）组成。通过在247 nm处的紫外吸光度检测阿托伐他汀和内标。药物和内标的平均回收率分别为95%和80%。检测限和定量下限分别为1 ng/ml和4 ng/ml，校准曲线在人血清中阿托伐他汀浓度范围为4-256 ng/ml时呈线性。研究了分析性能，并将该方法应用于12名健康志愿者中两种不同阿托伐他汀制剂的随机交叉生物等效性研究。
