硝酸甘油口腔崩解片的质量控制

Controlling the quality of nitroglycerin orally disintegrating tablets

目的：建立硝酸甘油口腔崩解片的质量控制方法。方法：采用高效液相色谱法，采用Kromasil C18（φ200mm×4．6mm，5μm）；以甲醇-乙腈-水（52：5：43）为流动相，流速0．7mL／min；检测波长为215nm，测定硝酸甘油口腔崩解片中硝酸甘油的含量。结果：在选定的液相色谱条件下，硝酸甘油浓度在0．035～0．065mg／mL范围内，峰面积与浓度呈良好的线性关系（r=O．9999），平均回收率为101．15％（n=9）。结论：该质量控制方法简便、稳定、准确，能有效地控制硝酸甘油口腔崩解片的质量。

Objective： To establish a quality control method for nitroglycerin orally disintegrating tablets. Methods： The content of nitroglycerin was measured by HPLC method on Kromasil C18 （φ200mm×4.6mm,5μm） column with a mixture of methanol-acetonitrilewater （52：5：43） as mobile phase at a flow rate of 0.7 mL/min under the wavelength of 215 nm. Results： Under the selected liquid chromatographic condition, the linear range of nitroglycerin was 0.035-0.065 mg/mL,r=0.999 9.The average recovery of nitroglycerin was 101.15% （n =9）. Conclusion： The method is convenient, stable and reliable for the quality control of nitroglycerin orally disintegrating tablets.