药学研究
藥學研究
약학연구
Journal of Pharmaceutical Research
2015年
12期
703-705
,共3页
乳痛安口服液%连翘苷%高效液相色谱法%含量测定%质量标准
乳痛安口服液%連翹苷%高效液相色譜法%含量測定%質量標準
유통안구복액%련교감%고효액상색보법%함량측정%질량표준
Rutong′an Oral Solution%Phillyrin%HPLC%Determination%Quality standard
目的：建立乳痛安口服液中连翘苷的含量测定方法，为其质量标准提高提供依据。方法采用反相高效液相色潽法测定乳痛安口服液中连翘苷的含量，并进行一系列方法学考察。色谱柱：Diamonsil C18（4.6 mm ×150 mm，5μm）；柱温：25℃；流动相：乙腈-水（25：75）；流速：1.0 mL·min -1；进样量：10μL；检测波长：277 nm。结果连翘苷在0.625~10.00μg·mL -1范围内线性关系良好（r =1.0000），乳痛安口服液供试品的稳定性以及所建立定量方法的专属性、重现性、精密度、加样回收率均符合要求，3个批次的乳痛安口服液中连翘苷的含量分别为14.78、15.31、15.40μg·mL -1。结论所建立的测定方法简便、稳定、专属性强、可重复性好，可以用于乳痛安口服液的质量控制。
目的：建立乳痛安口服液中連翹苷的含量測定方法，為其質量標準提高提供依據。方法採用反相高效液相色潽法測定乳痛安口服液中連翹苷的含量，併進行一繫列方法學攷察。色譜柱：Diamonsil C18（4.6 mm ×150 mm，5μm）；柱溫：25℃；流動相：乙腈-水（25：75）；流速：1.0 mL·min -1；進樣量：10μL；檢測波長：277 nm。結果連翹苷在0.625~10.00μg·mL -1範圍內線性關繫良好（r =1.0000），乳痛安口服液供試品的穩定性以及所建立定量方法的專屬性、重現性、精密度、加樣迴收率均符閤要求，3箇批次的乳痛安口服液中連翹苷的含量分彆為14.78、15.31、15.40μg·mL -1。結論所建立的測定方法簡便、穩定、專屬性彊、可重複性好，可以用于乳痛安口服液的質量控製。
목적：건립유통안구복액중련교감적함량측정방법，위기질량표준제고제공의거。방법채용반상고효액상색보법측정유통안구복액중련교감적함량，병진행일계렬방법학고찰。색보주：Diamonsil C18（4.6 mm ×150 mm，5μm）；주온：25℃；류동상：을정-수（25：75）；류속：1.0 mL·min -1；진양량：10μL；검측파장：277 nm。결과련교감재0.625~10.00μg·mL -1범위내선성관계량호（r =1.0000），유통안구복액공시품적은정성이급소건립정량방법적전속성、중현성、정밀도、가양회수솔균부합요구，3개비차적유통안구복액중련교감적함량분별위14.78、15.31、15.40μg·mL -1。결론소건립적측정방법간편、은정、전속성강、가중복성호，가이용우유통안구복액적질량공제。
Objective To establish a method for determination of phillyrin in Rutong′an Oral Solution and to develop a new quality standard. Methods An RP - HPLC method was adopted for the determination of phillyrin in Rutong′an Oral Solution. The HPLC conditions were as follows:Diamonsil C18(4. 6 mm × 150 mm,5 μm)column was used with column temperature 25 ℃;A mixture of acetonitrile - H2 O(25:75)served as mobile phase with flow rate 1. 0 mL·min - 1 ;The in-jection volume was 10 μL;The detection wavelength was 277 nm;The data acquisition time was 20 min and the theoretical plate number of phillyrin was over 3 000. Results The phillyrin showed a good linearity in the range of 0. 625 ~ 10. 00μg·mL - 1(r = 1. 000 0). The stability for samples extracted from Rutong′an Oral Solution,as well as the specialization,re-producibility,precision and recovery for the established quantitative method were in line with the requirements. The contents of phillyrin in the 3 batches of Rutong′ an Oral Solution samples were 14. 78,15. 31,15. 40 μg · mL - 1 ,respective-ly. Conclusion The established method was simple,stable with strong specificity and good repeatability,and can be ap-plied for quality control of Rutong′an Oral Solution.
