建立并验证了一种用于检测和定量经皮递送研究中阿托伐他汀、氟伐他汀、匹伐他汀和普伐他汀的新型 HPLC 方法。

A novel HPLC method developed and validated for the detection and quantification of atorvastatin, fluvastatin, pitavastatin and pravastatin during transdermal delivery studies.

机构信息

Centre of Excellence for Pharmaceutical Sciences, North-West University, Potchefstroom, South Africa.

Centre of Excellence for Pharmaceutical Sciences, North-West University, Potchefstroom, South Africa;, Email:

出版信息

Pharmazie. 2020 May 1;75(5):164-166. doi: 10.1691/ph.2020.0007.

DOI:10.1691/ph.2020.0007

PMID:32393420

Abstract

An HPLC method was developed and validated to quantify and identify several statins (atorvastatin, fluvastatin, pitavastatin and pravastatin) that were used during transdermal drug delivery. The method proved to be most effective with a Restek Ultra C, 250 x 4.6 mm, 5 μm column, a flow rate of 1.0 ml/min, UV detection at 240 nm and injection volume of 10 μl. The mobile phase used was acetonitrile/Milli-Q water with 0.1% orthophosphoric acid starting with 30% acetonitrile, which increased linearly to 70% (after 4 min) for up to 10 min and then re-equilibrated to start conditions. This HPLC method indicated linearity (correlation coefficient (R²) of 1) within the concentration range of 0.05-200.00 μg/ml and had an average recovery of 98-103%. Limit of detection (LOD) and limit of quantification (LOQ) showed that statins could still be identified at concentrations of 0.004-0.006 μg/ml with the exception of atorvastatin (quantifiable at 0.013-0.035 μg/ml). Specificity performed during method validation, confirmed that the method was suitable for accurate detection and quantification of the statins when included in the transdermal formulations with other excipients.

摘要

建立并验证了一种 HPLC 方法，用于定量和鉴定几种在经皮给药过程中使用的他汀类药物（阿托伐他汀、氟伐他汀、匹伐他汀和普伐他汀）。该方法在使用 Restek Ultra C、250 x 4.6 mm、5 μm 柱、流速为 1.0 ml/min、240nm 紫外检测和 10 μl 进样量时效果最佳。所用的流动相为乙腈/Milli-Q 水，内含 0.1%正磷酸，起始乙腈比例为 30%，在 4 分钟内线性增加至 70%（持续 10 分钟），然后重新平衡至起始条件。该 HPLC 方法表明在 0.05-200.00μg/ml 的浓度范围内具有线性（相关系数（R²）为 1），平均回收率为 98-103%。检测限（LOD）和定量限（LOQ）表明，除阿托伐他汀（可在 0.013-0.035μg/ml 范围内定量）外，他汀类药物仍可在 0.004-0.006μg/ml 的浓度下被识别。方法验证期间的特异性表明，该方法适用于在包含其他赋形剂的经皮制剂中准确检测和定量这些他汀类药物。