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目的:建立在线过程检测缬沙坦胶囊溶出度方法。方法:采用光纤传感过程分析技术(FODT)检测缬沙坦胶囊在pH6.8,pH4.5,pH1.2及水4种溶出介质中的溶出情况,并与中国药典方法相比较。结果:4种溶出介质中,缬沙坦在16.3～97.8μg.mL-1范围内线性关系良好(r>0.999),平均回收率101.9%。不同批次缬沙坦胶囊的制剂工艺稳定,均匀度好。缬沙坦胶囊在pH6.8和pH4.5缓冲液中30 min时溶出度大于80%,符合中国药典规定,但在pH1.2及水介质中,30 min时溶出度只有35.5%,55.6%。结论:FODT法将过程分析用于检测固体制剂溶出度不需取样而连续检测,可获取完整溶出曲线和相关数据。缬沙坦胶囊在不同溶出介质的溶出度明显不同。口服固体制剂药物的溶出度有必要考察不同pH的溶出介质。
OBJECTIVE: To establish an online method for the determination of valsartan capsule dissolution. Methods: The dissolution of valsartan capsule in four dissolution media of pH6.8, pH4.5, pH1.2 and water was detected by optical fiber sensing process analysis (FODT) and compared with the Chinese Pharmacopoeia. Results: Among the four dissolution media, valsartan showed a good linearity (r> 0.999) in the range of 16.3-97.8 μg.mL-1 with an average recovery of 101.9%. Different batches of valsartan capsules preparation process is stable, good uniformity. The dissolution rate of Valsartan capsules in pH6.8 and pH4.5 buffer was more than 80% at 30 min, which was in accordance with the requirements of the Chinese Pharmacopoeia. However, the dissolution rate of Valsartan was only 35.5% and 55.6% in pH1.2 and aqueous medium at 30 min, . Conclusion: The FODT method can be used to detect the dissolution rate of solid preparation continuously without sampling, and the complete dissolution curve and related data can be obtained. Valsartan dissolution rate in different dissolution media significantly different. Dissolution of oral solid preparations It is necessary to investigate dissolution media of different pH.