Stanisz Beata, Kania Lukasz
Department of Pharmaceutical Chemistry, Poznań University of Medical Sciences, Poznań, Poland.
Acta Pol Pharm. 2006 Nov-Dec;63(6):471-6.
A rapid high performance liquid chromatographic method was developed and validated for determination of atorvastatin in pharmaceutical dosage forms, and for evaluation of its stability in the solid phase. Separation of atorvastatin was successfully achieved on a C-18 column utilizing water--acetonitrile at the volumetric ratio of 48:52, adjusted to pH 2.0 with 80% ortho-phosphoric acid. The detection wavelength was 245 nm. The method was validated and the response was found to be linear in the drug concentration range of 0.04 mg/mL - 0.4 mg/mL. The mean values +/- RSD of the slope and the correlation coefficient were 8.192 +/- 0.260 and 0.999, respectively. The RSD values for intra- and interday precision were < 1.00% and 0.90%, respectively. The degradation kinetic of atorvastatin at 363 K in a relative humidity of 76.4% was observed to be autocatalytic first order reaction. The kinetic parameters were as follows: k (where k represents the velocity constant; s(-1)) = (1.42 +/- 0.19) 10(-6); t(0.5) (where t(0.5) represents the time needed for a 50% decay of atorvastatin; days) = 32.82 +/- 0.9; t(0.1) (where t(0.1) represents the time needed for a 10% decay of atorvastatin; days) = 13.86 +/- 0.8.
建立并验证了一种快速高效液相色谱法，用于测定药物剂型中的阿托伐他汀，并评估其在固相中稳定性。在C-18柱上，以体积比48:52的水 - 乙腈为流动相，用80%的正磷酸调节pH至2.0，成功实现了阿托伐他汀的分离。检测波长为245 nm。该方法经过验证，在0.04 mg/mL - 0.4 mg/mL的药物浓度范围内响应呈线性。斜率和相关系数的平均值±相对标准偏差分别为8.192±0.260和0.999。日内和日间精密度的相对标准偏差值分别<1.00%和0.90%。观察到阿托伐他汀在363 K、相对湿度76.4%条件下的降解动力学为自催化一级反应。动力学参数如下：k（其中k表示速度常数；s(-1)）=(1.42±0.19)×10(-6)；t(0.5)（其中t(0.5)表示阿托伐他汀降解50%所需时间；天）=32.82±0.9；t(0.1)（其中t(0.1)表示阿托伐他汀降解10%所需时间；天）=13.86±0.8。
