摘要
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。
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.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第12期1132-1134,共3页
China Pharmacy
