目的 考察輔酶Q10 在其異構(gòu)體檢測(cè)配制的正己烷溶液中的穩(wěn)定性情況。方法 參考《美國藥典》、《歐洲藥典》、《中國藥典》2010 年版等法定標(biāo)準(zhǔn)要求的輔酶Q10 原料異構(gòu)體檢測(cè)方法，最終采用《中國藥典》方法，選取5 批，3 個(gè)不同來源的輔酶Q10 產(chǎn)品，分別將異構(gòu)體檢測(cè)溶液置于棕色量瓶和透明量瓶中，放置0、3、5 h，對(duì)比異構(gòu)體檢測(cè)HPLC 圖譜各雜質(zhì)峰面積歸一化百分比的變化情況。結(jié)果 該研究通過一系列試驗(yàn)證實(shí)了異構(gòu)體檢測(cè)溶液在存放過程會(huì)發(fā)生降解，從而導(dǎo)致檢測(cè)結(jié)果的偏差。結(jié)論 輔酶Q10 異構(gòu)體檢測(cè)樣品溶液配制必須臨用新配，避光操作。

Objective To study the stability of coenzyme Q10 (CoQ10) in the isomer test solution. Methods Based on the CoQ10 isomer test method in USP, EP, and Chinese Pharmacopoeia 2010 (ChP2010), the method in ChP2010 is finally used. Five batches of CoQ10 products from three different sources were selected. and the difference of chromatogram area percentage on different storage conditions (brown and transparent flasks) and different storage time (0, 3, and 5 h) were compared. Conclusion This study proves that CoQ10 is gradually decomposed in isomer test solution by testing campaign, which results in the deviation of detection. The test solution must be prepared before use and operated away from light.