GC法测定凝胶膏剂中薄荷脑的含量

Determination of menthol in gel-unguentum by GC cataplasm

目的对已建立的凝胶膏剂中薄荷脑含量测定的气相色谱方法进行验证。方法依据《中国药典》2010年版(二部)附录药品质量标准分析方法验证[1],对所建立方法的准确度、精密度、专属性、检测限、线性、耐用性进行验证。结果薄荷脑浓度在4.500 5×10-5～1.050 1×10-4g.mL-1范围内线性关系良好(r=0.999 9),符合要求;不同浓度[0.0275 1,0.033 84和0.041 68(g/100 g)]制剂的回收率分别为98.5%(RSD=0.56%)、98.1%(RSD=0.76%)、98.6%(RSD=0.41%)。结论本方法快速、准确、分离度好、灵敏度高。

Objective To verify the established method for the determination of menthol in gel - unguentum by gas chromatography （ GC ）. Methods The verification was carried out based on the drugs quality specification analysis method in the appendix of Chinese Pharmacopoeia 2010 { edition two ）. The accuracy, precision, specificity ,limit of quantitation, linearity and durability of the established method were verified. Results The linear range of menthol was 4.500 5 × 10 ^-5 - 1. 050 1 × 10 ^-4 g . mL -1 [ r = 0. 999 9）. The recovery rates of different concentrations, including 0. 027 51,0. 033 84 and 0. 041 68（ g/100 g） , were 98.5% （ RSD = 0.56% ） , 98.1% （ RSD = 0.76% ） and 98.6% （ RSD = 0. 41% ） , respectively. Conclusion The established method was rapid, accurate with good resolution and high sensitivity for the determination of menthol content in gel - unguentum.