盐酸纳洛酮及其注射液中有关物质的测定

Determination of Related Substances in Naloxone Hydrochloride and Its Injection

建立盐酸纳洛酮及其注射液中有关物质的分离分析方法。采用Zorbax SB-C18柱;以乙腈-四氢呋喃-0.005mol·L-1辛烷磺酸钠溶液(用磷酸调节pH值至2.0)(20∶40∶940)为流动相A,以乙腈-四氢呋喃-0.005mol·L-1辛烷磺酸钠溶液(用磷酸调节pH值至2.0)(255∶60∶685)为流动相B进行梯度洗脱。盐酸纳洛酮及其注射液中有关物质均能完全分离,在测定范围内具有良好的线性和精密度。本方法具有简便、准确等特点,可用于盐酸纳洛酮及其注射液中有关物质的测定。

To establish a HPLC method for simultaneous determination of the related substances in naloxone hydrochloride and its injection. The related substances of naloxone hydrochloride and its injection were determined on a Zorbax SB-C18 column （4. 6mm×250mm, 5μm） with gradient elution. The mobile phase A was acetonitrile： tetrahydrofuran： 0. 005mol . L^-1 sodium octanesulphonate solution （using phosphoric acid adjust pH to 2.0） （20 ： 40 ： 940）, the mobile phase B was acetonitrile： tetrahydrofuran： 0. 005mol . L^-1 sodium octanesulphonate solution （using phosphoric acid adjust pH to 2.0） （255 ： 60 ： 685）. The detection wavelenth was 230nm. Good seperations for the related substances and naloxone hydrochloride were achieved with good precision and linearity. The HPLC method is simple and accurate. It is suitable to the determination of related substances in naloxone hydroehloride and its injection.