Complexation of diclofenac sodium with hydroxy propyl betacyclodextrin improves its solubility and stability in ampoule solution which is determined by HPLC

Abstract

Diclofenac sodium injection is widely used in medicine as antinflamatory and antirheumatic agent with a therapeutic value of 25 mg / ml. However, diclofenac sodium is poorly soluble which forms a problem in its manufacturing as an injection. The available commercial products of diclofenac sodium ampoules have used different types of solubilizing agents as benzyl alcohol which is an irritant in a concentration more than 3% while the other manufacturers used propylene glycol which has toxic impurities. In this present work, Diclofenac Sodium injection is prepared by using Hydroxy Propyl Beta Cyclodextrine ; a natural and safe excipient in formulation of ampoule solution which formed an inclusion complex compounds with Diclofenac Sodium ,render it very soluble and more stable. The finished product of ampoules were subjected to the stability study by storing the samples at 40°C and 75% RH for six months and the physico-chemical properties of the samples were tested at different periods. The results showed no change in appearance of the ampoules solution along the study time .In addition a reversed –phase high pressure liquid chromatographic method was developed and applied in studying the behavior of diclofenac Sodium in solution and its resistance to the high temperature challenger. The developed HPLC method was proved to be accurate and able to detect the degradation products of Diclofenac Sodium in solution.