黑龙江医药
黑龍江醫藥
흑룡강의약
HEILONGJIANG MEDICAL JOURNAL
2014年
4期
755-757,758
,共4页
洛芬待因缓释胶囊%磷酸可待因%有关物质%HPLC
洛芬待因緩釋膠囊%燐痠可待因%有關物質%HPLC
락분대인완석효낭%린산가대인%유관물질%HPLC
Codeine Sustained Release Capsules%Codeine Phosphate%Related Substances%HPLC
目的：建立HPLC法测定洛芬待因缓释胶囊中磷酸可待因有关物质的检测法。方法：固定相：Agilent ZORB-AXSB-C18(250mm×4.6mm，5μm)，流动相：0.03mol/L醋酸钠溶液（用冰醋酸调节PH值至3.5）-甲醇（93：7）；流速1.0ml/min；检测波长240nm。进样量40μl。结果：该色谱条件下，主成分与有关物质完全分离，各杂质分离度良好。在0.1219～4.874μg/ml范围内，吗啡的峰面积和浓度呈良好的线性关系，且回收率均符合规定要求。结论：本方法简便，重现性好，能够用于洛芬待因缓释胶囊的质量控制。
目的：建立HPLC法測定洛芬待因緩釋膠囊中燐痠可待因有關物質的檢測法。方法：固定相：Agilent ZORB-AXSB-C18(250mm×4.6mm，5μm)，流動相：0.03mol/L醋痠鈉溶液（用冰醋痠調節PH值至3.5）-甲醇（93：7）；流速1.0ml/min；檢測波長240nm。進樣量40μl。結果：該色譜條件下，主成分與有關物質完全分離，各雜質分離度良好。在0.1219～4.874μg/ml範圍內，嗎啡的峰麵積和濃度呈良好的線性關繫，且迴收率均符閤規定要求。結論：本方法簡便，重現性好，能夠用于洛芬待因緩釋膠囊的質量控製。
목적：건립HPLC법측정락분대인완석효낭중린산가대인유관물질적검측법。방법：고정상：Agilent ZORB-AXSB-C18(250mm×4.6mm，5μm)，류동상：0.03mol/L작산납용액（용빙작산조절PH치지3.5）-갑순（93：7）；류속1.0ml/min；검측파장240nm。진양량40μl。결과：해색보조건하，주성분여유관물질완전분리，각잡질분리도량호。재0.1219～4.874μg/ml범위내，마배적봉면적화농도정량호적선성관계，차회수솔균부합규정요구。결론：본방법간편，중현성호，능구용우락분대인완석효낭적질량공제。
Objective:Detection method for the determination of related substances of codeine phosphate codeine sustained re-lease capsules by HPLC method. Methods:The stationary phase:Agilent ZORBAX SB-C18 (250mm × 4.6mm, 5μm), mobile phase:0.03mol/L solution of sodium acetate (acetic acid to adjust the pH to 3.5 with glacial)-methanol (93:7);the flow rate was 1.0ml/min;the detection wavelength was 240nm. The injection volume was 40μL. Results:The chromatographic condition, the main ingredients were completely separated and related substances, the impurity separation degree of good. In 0.1219~4.874μg/ml range, there was a good linear relationship between peak area and concentration of morphine, and the recovery rate is in line with the requirements. Con-clusion:The method is simple, reproducible, and can be used for the quality control of codeine sustained release capsule.
