高效液相色譜雙波長檢測法測定維C銀翹片中4種組分的含量

董 麗, 孫祥德, 李 琴

(新鄉(xiāng)醫(yī)學(xué)院,河南新鄉(xiāng)453003)

高效液相色譜雙波長檢測法測定維C銀翹片中4種組分的含量

董 麗＊, 孫祥德, 李 琴

(新鄉(xiāng)醫(yī)學(xué)院,河南新鄉(xiāng)453003)

建立了高效液相色譜測定維C銀翹片中維生素C、對乙酰氨基酚、馬來酸氯苯那敏和綠原酸4種組分含量的方法。研究優(yōu)化了樣品提取的溶劑與超聲提取條件、色譜分離條件和檢測波長等,采用了Sinochrom ODS-BP(4.6 mm×200mm,5μm)色譜柱,以0.05mol/L KH2PO4(pH3.0,含1%三乙胺)-乙腈(75∶25,v/v)為流動相,雙檢測波長260nm和326nm等分離檢測條件。結(jié)果表明,維生素C、對乙酰氨基酚、馬來酸氯苯那敏和綠原酸的測定線性范圍均比較寬,方法平均回收率大于99.4%,相對標(biāo)準(zhǔn)偏差(RSD)小于1.8%(n=5),而且測定方法快速、簡便、準(zhǔn)確,非常適合維C銀翹片類藥物的質(zhì)量控制。

高效液相色譜法;雙檢測波長;維生素C;對乙酰氨基酚;馬來酸氯苯那敏;綠原酸;維C銀翹片

Abstract:A reversed-phase high performance liquid Chromatographic(RP-HPLC)method with dual wavelength detection was developed for the determination of vitamin C,paracetamol,chlorphenamine maleate and chlorogenic acid in Vitamin C Yinqiao Tablets.The separation was perform ed on a Sinochrom ODS-BP column with the mobile phase consisting of0.05mol/L KH2PO4(pH3.0,containing1%triethylamine and acetonitrile(75∶25,v/v).The detection wavelength was set at260nm(λ1)and326nm(λ2).The method linearities were wide and the average recoveries were more than99.4%.The relative standard deviations were less than 1.8%(n=5).This method is convenient,rap id and accurate.It is readily applied to the quality controls in the production process of Vitamin C Yinqiao Tablets.

Key words:high performance liquid Chromatography(HPLC);dual detection wavelengths;vitamin C;paracetamol;chlorphena mine maleate;chlorogenic acid;Vitamin C Yinqiao Tablets

維C銀翹片是由金銀花、連翹等13味中藥添加維生素C、對乙酰氨基酚和馬來酸氯苯那敏3種西藥成分所組成的復(fù)方制劑,具有辛涼解表、清熱解毒之功效,用于治療流行性感冒引起的發(fā)熱、頭疼、咳嗽、口干、咽喉疼痛等癥。目前,國家食品藥品監(jiān)督管理局國家藥品標(biāo)準(zhǔn)(WS3-B-4000-98-2003)中僅規(guī)定了維生素C和對乙酰氨基酚含量的測定,對其他成分無含量控制標(biāo)準(zhǔn)。金銀花是該制劑中中藥組方之君藥,綠原酸為其主要活性成分,對本方的臨床療效具有重要的作用;馬來酸氯苯那敏由于在該制劑中的含量較低,且不易混勻,現(xiàn)行的國家標(biāo)準(zhǔn)也未收載對其含量均勻度的測定。……