Division of Pharmaceutics, Rhodes University, Grahamstown, South Africa.
J Pharm Pharm Sci. 2010;13(4):558-70. doi: 10.18433/j3dk5f.
Sceletium plant species have been reported to contain psychoactive alkaloids, specifically belonging to mesembrine-type alkaloids. Sceletium is presently marketed through health shops and on the internet as dried plant powder and as pharmaceutical dosage forms and purported to be useful in the treatment of psychological disorders. However, there are no validated analytical methods and reference standards of the relevant alkaloids are not commercially available for use in the analysis and quality control of Sceletium products and dosage forms. Hence, the objective of this research was to isolate and characterize appropriate analytical markers for use in the assay and as well as markers for fingerprinting by high performance liquid chromatography (HPLC).
The separation of the relevant alkaloids was carried out on a C18 column and detected at a UV wavelength of 228 nm. The method was validated and used to assay the mesembrine-type alkaloids namely Δ(7)mesembrenone, mesembranol, mesembrenone, mesembrine and epimesembranol.
The calibration curves were found to be linear over the entire concentration range of 400-60,000 ng/ml with correlation coefficients >0.99. The accuracies of the relevant alkaloids were found to be between 94.8 and 103.6% with an inter-day relative standard deviation (RSD) of less than 2.8%. The precision studies showed inter-day RSD's of less than 3%. The recoveries were all within the range of 95 and 105% (RSD <4.5%) and the limits of quantitation (LOQ) and detection (LOD) were found to be 100 and 200 ng/ml respectively using the respective S/N ratios of 3 and 10. Conclusions. An HPLC method for the quantitative analysis of Δ(7)mesembrenone, mesembranol, mesembrenone, mesembrine and epimesembranol in Sceletium plant material has been developed and validated. This assay method can be applied for the quality control of Sceletium plant material which is used as an African Traditional Medicine for the treatment of psychological disorders.
已报道西翠果植物物种含有致幻生物碱，特别是属于美沙比林型生物碱。西翠果目前通过健康商店和互联网以干燥植物粉末的形式以及作为药物剂型销售，并被认为对治疗心理障碍有用。然而，目前还没有经过验证的分析方法，也没有商业上可用于分析和质量控制西翠果产品和剂型的相关生物碱的参考标准。因此，本研究的目的是分离和表征适当的分析标记物，用于测定和高效液相色谱（HPLC）指纹图谱。
在 C18 柱上进行相关生物碱的分离，并在 228nm 的紫外波长下检测。该方法经过验证，用于测定美沙比林型生物碱，即Δ（7）美沙比林酮、美沙醇、美沙比林酮、美沙林和表美沙醇。
发现校准曲线在整个浓度范围 400-60,000ng/ml 内呈线性，相关系数>0.99。相关生物碱的准确度在 94.8%至 103.6%之间，日内相对标准偏差（RSD）小于 2.8%。精密度研究显示日内 RSD 小于 3%。回收率均在 95%至 105%（RSD<4.5%）范围内，定量限（LOQ）和检测限（LOD）分别为 100ng/ml 和 200ng/ml，使用各自的 S/N 比 3 和 10。结论：已开发并验证了一种用于定量分析西翠果植物材料中美沙比林酮、美沙醇、美沙比林酮、美沙林和表美沙醇的 HPLC 方法。该测定方法可用于作为治疗心理障碍的非洲传统药物的西翠果植物材料的质量控制。
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