马来酸噻吗洛尔眼用凝胶剂的含量测定及药效研究

Study on Content Determination and Efficacy of Timolol Maleate Ophthalmic Gel

用反相高效液相色谱(RP-HPLC)法测定了马来酸噻吗洛尔眼用凝胶剂中噻吗洛尔的含量,并对制剂的药效进行了考察.色谱条件:Diamonsil C18色谱柱(4.6 mm×250 mm,5μm),流动相为甲醇-水-三乙胺(50∶50∶0.1,磷酸调节pH值到5.0),流动相流速1.0 mL.min-1,检测波长295 nm,柱温30℃.在上述色谱条件下,分别进行了线性、精密度、稳定性、回收率、样品含量测定等实验.结果表明,本检测方法简便、精确,适于马来酸噻吗洛尔眼用凝胶剂中噻吗洛尔含量的测定.该药物凝胶剂的药效优于滴眼液.

It is studied that the efficacy of Timolol Maleate ophthalmic gel in this paper.The content of Timolol in the gel was determined by RP-HPLC method.The chromatographic conditions were as following: Diamonsil C_(18) column(4.6 mm×250 mm,5 μm) at a temperature of 30 ℃,the mobile phase consisted of methanol-water-triethylamine(50∶50∶0.1,adjust pH to 5.0 with phosphoric acid) at a flow rate of 1.0 mL·min^(-1),the detection wavelength was set at 295 nm.Under the optimized chromatographic conditions,linearity,precision,stabilization,recovery and content determination of Timolol were carried out,respectively.The result showed that the method was convenient,accurate and suitable for the content determination of Timolol Maleate ophthalmic gel,and the efficacy of the gel was better than that of eye drops.