摘要
目的建立愈酚伪麻待因口服溶液中有关物质的检查方法。方法采用反相高效液相色谱法:DiamonsilTM-C18柱,乙腈-0.01mol·L-1的磷酸二氢钾(内含0.002mol·L-1的庚烷磺酸钠,用磷酸调pH=3.0)(体积比30∶70)为流动相,流速为1mL·min-1,检测波长为215nm,柱温为室温。结果本文方法可检出愈酚伪麻待因口服溶液中主药愈创木酚甘油醚的主要杂质游离愈创木酚,并能检出经氧化、酸、碱等破坏试验所产生的降解产物。结论该法可用于愈酚伪麻待因口服溶液中有关物质的检查。
Objective To establish a HPLC method for detection of related substances in compound guaifenesin, pseudoephedrine hydrochloride and codeine phosphate oral solution. Methods A RP-HPLC method was established with DiamonsilTM C18 column. The mobile phase was acetonitfile-0.01 mol ·L^-1 potassium dihydrogen phosphate solution （with 0. 002 mol ·L^-1 sodium 1-heptanesulfonate, adjusted to pH3.0 with phosphoric acid） （ v ： v = 30 ： 70 ） , the flow rate was 1 mL·min^-1, and the detection wavelength was 215 nm. Results The related substances and its main degradation products can be detected by this HPLC method. Conclusion The method could be used for detection of the related substances in compound guaifenesin, pseudoephedrine hydrochlofide and codeine phosphate oral solution.
出处
《广东药学院学报》
CAS
2009年第4期365-367,共3页
Academic Journal of Guangdong College of Pharmacy
关键词
愈酚伪麻待因
口服溶液
有关物质
高效液相色谱法
Compound guaifenesin, pseudoephedrine hydrochloride and codeine phosphate oral solution
related substances
HPLC
