RP-HPLC法测定单硝酸异山梨酯鼻腔喷雾剂的含量和有关物质

目的:建立测定单硝酸异山梨酯鼻腔喷雾剂含量及有关物质的方法。方法:采用反相高效液相色谱法。色谱柱为Di-amonsil C18柱,流动相为甲醇-水(30∶70),流速为1.0mL·min-1,检测波长为210nm,进样量为20μL;峰面积定量采用外标法。结果:单硝酸异山梨酯回归方程为Y=7892.7X+2980.7(r=0.9999),检测浓度在5～150μg·mL-1范围内与峰面积积分值线性关系良好;最低检出浓度为20ng·mL-1;高、中、低浓度日内、日间精密度的RSD在0.31%～0.93%之间;重复性试验RSD=0.69%(n=9);样品的平均回收率为101.02%(RSD=1.12%,n=9)。结论:该法准确、可靠、重复性好,可用于单硝酸异山梨酯鼻腔喷雾剂的含量及有关物质的测定。

Content Determination of Related Substances of lsosorbide Mononitrate Nasal Sprays by RP-HPLC

To establish the method for the content determination of Isosorbide mononitrate nasal sprays and its related substances. METHODS： RP-HPLC method was adopted. The chromatographic column was Diamonsil C18 column. The mobile phase consisted of methanol-water （30：70） at flow rate of 1.0μg·mL^-1. The detection wavelength was set at 210 nm. The in- jection volurrm was 20 μL, and the external standard was adopted. RESULTS： The linear regression equation was Y=7 892.7X＋ 2 980.7 （r=0.999 9）, and the linear range of isosorbide mononitrate was 5-150 μg·mL^-1. The lowest detection limit was 20 ng·mL^-1. The RSD of intra-day and inter-day under low, medium and high concentrations were 0.31%-0.93%. The RSD of repeatability test was 0.69% （n=9）. The average recoveries of samples was 101.02% （RSD=1.12%, n=9）. CONCLUSION： The method is accurate, reliable and good reproducible. It is very suitable for the content determination of Isosorbide mononitrate nasal sprays and its related substances.