Etodolak'ın stabilite göstergeli sıvı kromatografisi ile ilaç dozaj şekillerinden tayini
Özet
A HPLC-UV method is presented for the determination of Etodolac. In this method; a reversed-phase column (Gemini 5 µ C-18, 110 A, 100 x 4.6 mm.) with a mobile phase of acetonitril: water: fosforik asit (50:50:0,25; v/v/v ) at 1,5 ml/min flow rate was used to achieve a good separation, with a detection of 270 nm. The chromatographic separation was performed at 30 oC.System suitability tests were carried out on the chromatogram of freshly prepared standard solutions to check various parameters such as resolution, selectivity, asymmetry and capacity factors as a part of validation procedure. The proposed methods have been extensively validated. Linearity was obtained in the concentration range of 0,0088-0.78 mg/ml for etodolac. In order to demonstrate the validity and applicability of the proposed HPLC method, recovery tests were carried. High percentage recovery shows that the method is free from the interferences of the commonly used excipients and additives in the formulations of drugs. Confirmation of the method stability, possible co-elution with other impurities and excipients, is tested by LC/MS system. Both assay and impurity results are compared with the result of LC/MS system. As a result, it can be concluded that HPLC assay method is stability indicating method.The present HPLC study purposes a rapid, simple, precise and accurate method for the simultaneous determination of etodolac, in raw material and pharmaceutical formulations. The proposed method is suitable for quality control laboratories, where economy and time are essential.