高效液相色谱法测定控释贴片中妥洛特罗的含量

Determination of tulobuterol in tulobuterol transdermal patch by HPLC

目的：建立高效液相色谱法测定妥洛特罗控释透皮贴片中药物含量的方法。方法：以三氯甲烷为萃取溶剂，超声10min充分提取贴片中药物，采用Promosil C18（4．6mm×250mm，5μm）色谱柱，甲醇－0．0015mol·L^-1庚烷磺酸钠溶液（以pH4．0的醋酸-醋酸钠缓冲液配制）（55：45）为流动相；流速1．0mL·min^-1；检测波长：220nm；柱温：30℃。结果：妥洛特罗在5～100μg·mL^-1范围内线性关系良好（r=0．9999），平均回收率为100．29％（RSD为1．23％，n=6）。结论：本方法准确可靠，稳定性好，可用于妥洛特罗控释贴片的质量控制。

OBJECTIVE To establish a high performance liquid chromatography （HPLC） method for the content determination of tulobuterol in transdermal patch. METHODS Chloroform was used as the extracted solvent, and the sample was processed ultrasonically for 10 min. A Promosil C18 column （4. 6 mm 250 mm, 5 μm） was adopted and the mobile phrase consisted of methanol-sodium heptanesulfonate solution（prepared by pH 4. 0 acetic acid-sodium acetate buffer solution）（55：45）at a flow rate of 1. 0 mL·min^-1. The detection wavelength was settled at 220 nm. The column temperature was maintained at 30 ~C. RESULTS The standard curve was fine linear in the range of 5 - 100 mg· L^-1 （r = 0. 999 9）. The average recovery rate is 100. 29% and RSD is 1.23%（n = 6）. The precision and stabilization of this method are all in accord with the test requirement. CONCLUSION The method is accurate,reliable, easy,and suitable for the quality control of tulobuterol transdermal patch.