Determination of dissolution of piroxicam patch and evaluation of the results of different measurement methods
10.19778/j.chp.2024.02.004
- VernacularTitle:吡罗昔康贴剂溶出度的测定及不同测定方法结果的评估
- Author:
Xun MA
1
;
Xia JIANG
;
Rui MAO
;
Qiang WEN
;
Lihui YIN
;
Hua CHEN
Author Information
1. 中国食品药品检定研究院,国家药品监督管理局化学药品质量研究与评价重点实验室,北京 102629
- Keywords:
piroxicam patch;
dissolution;
paddle over disk method;
rotating cylinder method;
vertical diffusion cell method
- From:
Drug Standards of China
2024;25(2):134-140
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Different methods were used to determine the dissolution of piroxicam patch,and the disso-lution results were evaluated,in order to select a determination method that could more accurately reflect the drug release process of piroxicam patch,so as to provide a reference for the scientific and accurate evaluation of drug quality.Methods:The liquid chromatography method for the detection of piroxicam was established,and the 24 hour dissolution curves of piroxicam patch were investigated by paddle over disk method,rotating cylinder method and vertical diffusion cell method,and the dissolution curves were compared by f1 difference factor method,f2 simi-larity factor method and Weibull model fitting,and the in vitro dissolution behavior of different methods was evalua-ted.Results:Piroxicam had a good linear relationship in the range of 1-150 μg·mL-1(r=1.000),the accura-cy was 100.9％(n=9),the precision was 1.7％(n=9),and the sample solution was stable within 72 hours.The results of the comparison of dissolution curves showed that the dissolution of piroxicam patch was more in line with the Weibull model.Under the same conditions of dissolution medium and temperature,there was little differ-ence between the paddle over disk method and rotating cylinder method,and there was a possibility of substitution for each other,and there were significant differences between the vertical diffusion cell method and the other two methods.Conclusion:The vertical diffusion cell method is more in line with the dissolution process of drugs in actual use,and provides more references for quality evaluation.
