中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2014年
16期
49-50
,共2页
普卢利沙星%NM394%有关物质%反相高效液相色谱法
普盧利沙星%NM394%有關物質%反相高效液相色譜法
보로리사성%NM394%유관물질%반상고효액상색보법
prulifloxacin%NM394%related substance%RP - HPLC
目的：采用反相高效液相色谱（RP - HPLC）法测定普卢利沙星片中 NM394含量及有关物质。方法色谱柱为 Phenomenex C18柱（150 mm ×4.6 mm，5μm），流动相 A 为0.025 mol / L 磷酸二氢钠溶液（用三乙胺调 pH 为6.0）、B 为乙腈，梯度洗脱，流速1.0 mL / min，检测波长276 nm。结果 NM394质量浓度在1.2~28.8μg / mL 范围内与峰面积呈良好的线性关系，r =0.9991（ n =6）。NM394低、中、高3个质量浓度的平均回收率分别为98.8%，99.7%，99.4%，RSD 分别为0.99%，0.61%，0.43%( n =3)。结论该方法测定普卢利沙星片中 NM394含量及有关物质，方法便捷、准确、专属性好。
目的：採用反相高效液相色譜（RP - HPLC）法測定普盧利沙星片中 NM394含量及有關物質。方法色譜柱為 Phenomenex C18柱（150 mm ×4.6 mm，5μm），流動相 A 為0.025 mol / L 燐痠二氫鈉溶液（用三乙胺調 pH 為6.0）、B 為乙腈，梯度洗脫，流速1.0 mL / min，檢測波長276 nm。結果 NM394質量濃度在1.2~28.8μg / mL 範圍內與峰麵積呈良好的線性關繫，r =0.9991（ n =6）。NM394低、中、高3箇質量濃度的平均迴收率分彆為98.8%，99.7%，99.4%，RSD 分彆為0.99%，0.61%，0.43%( n =3)。結論該方法測定普盧利沙星片中 NM394含量及有關物質，方法便捷、準確、專屬性好。
목적：채용반상고효액상색보（RP - HPLC）법측정보로리사성편중 NM394함량급유관물질。방법색보주위 Phenomenex C18주（150 mm ×4.6 mm，5μm），류동상 A 위0.025 mol / L 린산이경납용액（용삼을알조 pH 위6.0）、B 위을정，제도세탈，류속1.0 mL / min，검측파장276 nm。결과 NM394질량농도재1.2~28.8μg / mL 범위내여봉면적정량호적선성관계，r =0.9991（ n =6）。NM394저、중、고3개질량농도적평균회수솔분별위98.8%，99.7%，99.4%，RSD 분별위0.99%，0.61%，0.43%( n =3)。결론해방법측정보로리사성편중 NM394함량급유관물질，방법편첩、준학、전속성호。
Objective To adopt the RP - HPLC method to determine the NM394 content and related substances in Prulifloxacin Tablets. Methods The separation was performed on The Phenomenex C18 column(150 mm × 4. 6 mm,5 μm). The mobile phase A was 0. 025 mol / L sodium phosphate monobasic dihydrate solution(adjusting to pH = 6. 0 with triethylamine);the mobile phase B was ace-tonitrile. The flow rate was 1. 0 mL / min with the gradient elution. The detection wavelength was 276 nm. Results The mass concentra-tion of NM394 in the range of 1. 2 - 28. 8 μg / mL exhibited good linear relation with the peak area( r = 0. 999 1,n = 6). The average recovery rates in the high,middle and low mass concentrations were 98. 8% ,99. 7% and 99. 4%( n = 3) respectively,with RSD of 0. 99% ,0. 61% and 0. 43% ( n = 3 ) respectively. Conclusion The method is proved to be quick,simple and accurate and is suitable for the determination of the NM394 content and its related substances in Prulifloxacin Tablets.
