Centre of Excellence for Pharmaceutical Sciences (Pharmacen™), Cape Town, South Africa; North-West University, Potchefstroom; Afrigen Biologics (Pty) Limited, Cape Town, South Africa.
Centre of Excellence for Pharmaceutical Sciences (Pharmacen™), Cape Town, South Africa.
Pharmazie. 2021 Dec 5;76(12):583-587. doi: 10.1691/ph.2021.1164.
A novel high performance liquid chromatography (HPLC) method was developed and validated to simultaneously analyse all statins currently available globally (atorvastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin). A Venusil XBP C(2) reverse phase column (150 x 4.6 mm) with a 5 μm particle size was used. The gradient conditions started at 25% acetonitrile, which linearly increased to 90% after 1.0 min, held at 90% until 6.5 min, and lastly, re-equilibrated to starting conditions. The mobile phase consisted of acetonitrile/water and 0.005 M (0.2%) octane sulphonic acid-Na (pH 3.5). The flow rate was set at 1.0 ml/min with a 10 μl injection volume. The HPLC method indicated linearity ( =0.9999) within the concentration range of 0.2-206.4 μg/ml. The limit of detection (LOD) and limit of quantification (LOQ) values were found to be within the permissible criteria of ≤15% and ≤20%, respectively. Following an appropriate investigation of all the parameters for method validation, it was confirmed that the HPLC method was successfully validated and proven to be accurate to simultaneously quantify statins even in combination with other excipients used during the formulation of nano-emulsions and nano-emulgels.
建立并验证了一种新型高效液相色谱（HPLC）方法，用于同时分析目前全球所有可用的他汀类药物（阿托伐他汀、氟伐他汀、洛伐他汀、美伐他汀、匹伐他汀、普伐他汀、罗伐他汀、辛伐他汀）。使用 Venusil XBP C(2)反相柱（150 x 4.6mm），粒径为 5μm。梯度条件从 25%乙腈开始，1.0 分钟线性增加到 90%，保持 90%直至 6.5 分钟，最后重新平衡至起始条件。流动相由乙腈/水和 0.005 M（0.2%）辛烷磺酸-Na（pH 3.5）组成。流速设定为 1.0ml/min，进样量为 10μl。HPLC 方法表明在 0.2-206.4μg/ml 的浓度范围内具有线性（=0.9999）。检测限（LOD）和定量限（LOQ）值均在允许标准范围内，分别为≤15%和≤20%。对方法验证的所有参数进行适当考察后，证实该 HPLC 方法成功验证，可准确同时定量他汀类药物，甚至在与纳米乳液和纳米乳凝胶制剂过程中使用的其他赋形剂结合使用时也可准确定量。
