加巴喷丁片剂的溶出度研究

Study on Dissolubility of Gabapentin Tablets

目的建立测定加巴喷丁片剂溶出度的方法。方法以茚三酮光度法测定加巴喷丁片剂含量,测定波长为570 nm;采用转篮法,以900 mL水为溶出介质,转速为100 r/min,温度(37±0.5)℃,对5批加巴喷丁片剂在8,10,12,15,30 min内进行溶出度均一性和批间重现性试验。结果与结论样品溶出均一性良好,溶出度均大于90%,茚三酮光度法可用于测定该产品的溶出度。

Objective To establish a method for determining the dissolution rate of Gabapentin Tablets. Methods The content of Gabapentin Tablets was determined by the ninhydrin photometric method with the detection wavelength of 570 nm. With 900 mL water as solvent, the rotating speed of 100 r/min and the temperature of （37±0.5）℃, the homogeneity of dissolution rate and the batch-to-batch reproducibility in 5 batches of Gabapentin Tablets were determined within 8, 10, 12, 15, 30 min by the rotating basket method. Results and Conclusion The dissolution homogeneity of five batches of samples is good and the dissolution rates all were above 90%. The ninhydrin photometric method can be used to determine the dissolution rate of this products.