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目的:建立尼索地平片的溶出度测定方法。方法:根据《中国药典》2010年版二部附录XC第二法对其溶出度进行检查,以含0.05%十二烷基硫酸钠(SDS)的0.1 mol·L-1的盐酸溶液600 ml为溶出介质,转速为75 r·min-1,采用紫外分光光度法,在238 nm波长处测定尼索地平片的吸光度。结果:尼索地平在4~14μg·ml-1的浓度范围内与吸光度呈良好线性关系(r=0.999 9),平均回收率为100.5%,RSD为1.1%(n=9)。结论:该方法简便准确可靠,可用于尼索地平片的溶出度测定。
Objective: To establish a method for the determination of dissolution of nisoldipine tablets. Methods: According to “Chinese Pharmacopoeia” 2010 edition two appendix XC second method to check its dissolution, with 0.05% sodium dodecyl sulfate (SDS) 0.1mol · L-1 hydrochloric acid solution 600 ml as the dissolution Medium, speed 75 r · min-1, using ultraviolet spectrophotometry, at 238 nm wavelength measured absorbance of nisoldipine tablets. RESULTS: Nisoldipine had a good linear relationship with absorbance (r = 0.999 9) at an average concentration of 4-14 μg · ml-1 with an average recovery of 100.5% and a RSD of 1.1% (n = 9). Conclusion: This method is simple, accurate and reliable and can be used for the determination of dissolution of nisoldipine tablets.