复方左炔诺孕酮片溶出度测定方法研究

Research on Determination Method for Dissolution of Compound Levonorgestrel Tablets

目的：建立复方左炔诺孕酮片的溶出度测定方法。方法：采用桨法,以0.1%SDS的0.1 mol/L HCl溶液500 m L为溶剂,转速为75 r/min,30 min时取样。采用高效液相色谱法测定,C18柱（4.6 mm×250 mm,5μm）为固定相,以乙腈-水（60∶40）为流动相,流速为1.0 m L/min。左炔诺孕酮采用紫外检测器检测,波长为247 nm;炔雌醇采用荧光检测器检测,激发波长为285 nm,发射波长为310 nm。结果：左炔诺孕酮在0.059 88-0.359 3μg/m L浓度范围内,线性关系良好;炔雌醇在0.012 19-0.073 15μg/m L浓度范围内,线性关系良好。左炔诺孕酮平均回收率为99.2%,炔雌醇平均回收率为99.0%。结论：建立了测定复方左炔诺孕酮片溶出度的新方法,此法方法重复性好,所得结果稳定可靠,可有效控制药品的质量。

Objective： To develop a method for determination of the dissolution of compound levonorgestrel tablets. Methods： The 0.1 mol/L hydrochloric acid solution containing 0.1% sodium dodecyl sulfate was used as a solvent, and the paddle was rotated at a rate of 75 r/min for 30 min, afterwards samples were taken and determined by HPLC using C18colume（4.6 mm × 250 mm, 5 μm） as a stationary phase and acetonitrile-water（ 60 ∶40） as a mobile phase. The flow rate was 1.0 m L/min. An ultraviolet spectrophotometer set at a wavelength of 247 nm was used for levonorgestrel analysis, and a spectrofluorometric detector was used for ethinylestradiol analysis at an excitation wavelength of 285 nm and an emission wavelength of 310 nm. Results： The linear ranges of levonorgestrel and ethinylestradiol concentrations were 0.059 88 -0.359 3 and 0.012 19 - 0.073 15 μg/m L,while the average recovery rates were 99.2% and 99.0%, respectively. Conclusion： A novel method for determination of dissolution of compound levonorgestrel tablets was developed, which was reproducible, stable and reliable, and might be used for quality control of drugs.