中国医药科学
中國醫藥科學
중국의약과학
CHINA MEDICINE AND PHARMACY
2014年
9期
118-120,123
,共4页
苯扎贝特酰化物%有关物质%系统适用性
苯扎貝特酰化物%有關物質%繫統適用性
분찰패특선화물%유관물질%계통괄용성
Bezafibrate acylate%Related substances%System suitability
目的:建立苯扎贝特酰化物中有关物质的测定方法。方法 NUCLEOSIL 100-5 C18(5μm)0.125m×4mm;流动相为磷酸二氢钾溶液(2.72g/L,用磷酸调节pH2.3)︰甲醇=4︰6;检测波长:228nm;流速:1.0mL/min。结果苯扎贝特酰化物与主要杂质能得到有效分离,各杂质在0.2~3.5μg/mL范围内呈良好线性关系。结论本测定方法灵敏度高,准确可靠,可以控制苯扎贝特酰化物中有关物质的含量。
目的:建立苯扎貝特酰化物中有關物質的測定方法。方法 NUCLEOSIL 100-5 C18(5μm)0.125m×4mm;流動相為燐痠二氫鉀溶液(2.72g/L,用燐痠調節pH2.3)︰甲醇=4︰6;檢測波長:228nm;流速:1.0mL/min。結果苯扎貝特酰化物與主要雜質能得到有效分離,各雜質在0.2~3.5μg/mL範圍內呈良好線性關繫。結論本測定方法靈敏度高,準確可靠,可以控製苯扎貝特酰化物中有關物質的含量。
목적:건립분찰패특선화물중유관물질적측정방법。방법 NUCLEOSIL 100-5 C18(5μm)0.125m×4mm;류동상위린산이경갑용액(2.72g/L,용린산조절pH2.3)︰갑순=4︰6;검측파장:228nm;류속:1.0mL/min。결과분찰패특선화물여주요잡질능득도유효분리,각잡질재0.2~3.5μg/mL범위내정량호선성관계。결론본측정방법령민도고,준학가고,가이공제분찰패특선화물중유관물질적함량。
Objective To establish an HPLC method for detection of the related substances. Methods The analytical column was NUCLEOSIL 100-5 C18 column (4.0mm×12.5cm, 5μm). The mobile phase was potassium dihydrogen phosphate (2.72g/L, adjust to pH 2.3 with phosphoric acid):methanol=4:6 The flow rate was 1.0mL/min. The wavelenth was 228nm. Results A satisfactory separation condition for the five related impurities, the impurities standard curve was good linear over the range of 0.2-3.5μg/mL. Conclusion The method is sensitive and accurate and it can be used to determine the relateted substances of bezafibrate acylate.