Establishment of the quality research method for diclofenac potassium cataplasms and the preparation evaluation / 国际药学研究杂志

ABSTRACT

Objective: To prepare the new diclofenac potassium cataplasms, establish a quality research method and evaluate the preparation quality by the established method. Methods: A high performance liquid chromatography(HPLC)was performed on an ODS column(the column temperature 35℃)using the methanol-4% glacial acetic acid solution(80 20, V/V)as mobile phase, and the detection wavelength was set at 276 nm. Diclofenac potassium was extracted with methanol, and the adhesion, content and uniformity of potassium diclofenac were measured. The release of diclofenac potassium from the cataplasms was determined in accordance with the fourth method of the XD release methods in the Appendix of the Chinese Pharmacopoeia. Results: The average maximum number of steel ball stuck in the cataplasms in the initial adhesion test was No. 6. Under the HPLC conditions, potassium diclofenac showed good linearity within the concentration range of 400-800 μg/ml, with the average sample recovery rate 1.33 % and RSD< 1.93%(n=6). The methodological studies for the drug release test for the diclofenac potassium cataplasms showed that the diclofenac potassium showed a good linearity within the range of 1-50 μg/ml in the drug release test, and the precision and recovery well satisfied the requirements of Pharmacopoeia. The content uniformity of the cataplasms was in accordance with the Pharmacopoeia. The release amounts of the cataplasms in 2, 5 and 8 hours were 20%-45%, 40%-80% and more than 70% of the labeled amount, respectively, and the release curve followed the first-order release equation. Conclusion: The established HPLC method is sensitive, accurate, easily operable and reproducible, which could be used for the quality control of diclofenac potassium cataplasms. The prepared diclofenac potassium cataplasms were of uniform content and showed characteristics of the sustained release, which is expected to be developed to a new preparation of diclofenac potassium.