Biju S S, Ahuja Alka, Rafiullah M R M, Khar Roop K
Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi 110062, India.
J Pharm Biomed Anal. 2005 Jun 1;38(1):41-4. doi: 10.1016/j.jpba.2004.11.034. Epub 2004 Dec 24.
A HPTLC method has been developed and validated for the determination of tea tree oil from cosmeceutical formulations. Tea tree oil concentration was estimated by analyzing the terpinen-4-ol content. The method employed TLC aluminium plates precoated with silica gel 60F-254. The solvent system consisted of toluene and ethyl acetate in the ratio 85:15. The calibration curve of terpinen-4-ol was linear in the range of 100-900 ng. The polynomial regression data for the calibration plots showed a good linear relationship with r(2)=0.9949. The Rf value of terpinen-4-ol was found to be 0.62+/-0.05. The method was validated for precision and accuracy. The minimum detectable amount was found to be 60 ng. The limit of quantitation was found to be 100 ng. The drug content was within the limits (+/-5% of the labeled content of the formulations). The recovery of tea tree oil was greater than 99%. The method was found to be simple, sensitive, precise, accurate and specific for estimation of tea tree oil from formulations.
已开发并验证了一种用于测定药妆配方中茶树油的高效薄层色谱法(HPTLC)。通过分析萜品-4-醇含量来估算茶树油浓度。该方法采用预涂硅胶60F-254的TLC铝板。溶剂系统由比例为85:15的甲苯和乙酸乙酯组成。萜品-4-醇的校准曲线在100 - 900 ng范围内呈线性。校准图的多项式回归数据显示出良好的线性关系,r(2)=0.9949。发现萜品-4-醇的比移值(Rf值)为0.62±0.05。该方法在精密度和准确度方面得到了验证。最低检测量为60 ng。定量限为100 ng。药物含量在规定范围内(制剂标示含量的±5%)。茶树油的回收率大于99%。该方法被发现对于从配方中估算茶树油而言简单、灵敏、精密、准确且具有特异性。