DETERMINATION OF ISOSORBIDE MONONITRATE (ISMN) AND ITS TWO RELATED SUBSTANCES IN ISOSORBIDE MONONITRATE AND SODIUM CHLORIDE INJECTION
AbstractA high-performance liquid chromatography (HPLC) method has been developed for the determination of isosorbide mononitrate and its related substances in isosorbide mononitrate and sodium chloride injection. An C18 column (5μm, 250 ×4.6 mm) was used for the determination, with methanol and water (25:75,v/v)as the mobile phase at the flow rate of 1 mL min−1. The detection wavelength was 210 nm. The related substances were quantitated versus an external standard. The method was capable of resolving all of the two known related substances. The two related substances were isosorbide dinitrate (ISDN) and 2- isosorbide mononitrate (2-ISMN), respectively. The method was successfully applied to quantify related substances. The limits of detection of isosorbide mononitrate, isosorbide dinitrate and 2-isosorbide mononitrate (2-ISMN) were all 0.3ng. And the limits of quantitation of isosorbide mononitrate, isosorbide dinitrate and 2- isosorbide mononitrate (2-ISMN) were all 0.8ng. The method was found to be accurate, precise, specific, linear and sensitive, for the determination
Article Information
5
4531-4536
446KB
2151
English
IJPSR
Liandong Hu *, Yanjing Shi and Na Gao
School of Pharmaceutical Sciences & Key Laboratory of Pharmaceutical Quality Control of Hebei Province, Hebei University. No.180, WuSi Road, Baoding, 071002 PR China
hbupharm@126.com
06 July, 2013
17 October, 2013
16 November, 2013
http://dx.doi.org/10.13040/IJPSR.0975-8232.4(12).4531-36
01 December 2013
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