Development of the original method for determination of diclofenac sodium in different drug dosage forms


  • V. A. Khanin LLC Pharmaceutical Company “Zdorovye”, Ukraine
  • O. M. Kotenko National University of Pharmacy, Ukraine
  • O. O. Moiseev Ivan Kozhedub Kharkiv University of Air Force, Ukraine
  • O. V. Dorovskyy LLC Pharmaceutical Company “Zdorovye”, Ukraine



diclofenac sodium, high-performance liquid chromatography, quantitative determination, validation


There are a number of methods for determination of diclofenac sodium in medicines; however, they all differ by analytical methods involved depending on the drug dosage form. The aim of the study was to develop the universal HPLC-method for determination of diclofenac sodium, which would be suitable for quantitative determination of this active pharmaceutical ingredient (API) in various dosage forms. In our study a chromatograph 2695 with a photodiode array detector 2996 (Waters Corp., USA) and the column containing the C18 phase with the particle size of 5 mm, ER-182 balances (AND company, Japan), measuring glassware of class A were used. Validation of the method has been conducted in accordance with the requirements of the State Pharmacopoeia of Ukraine (SPhU). The HPLC-method for determination of diclofenac sodium in different drug dosage forms and UPLCvariant of this method for conducting rapid measurements have been developed. Validation of the methods proposed has been conducted, their suitability for determining diclofenac sodium in different drug dosage forms, as well as the insignificant effect of the sample preparation on the analysis results have been proven. The analysis of various medicines has been performed; the possibility of using the methods developed for the analysis of existing medicines based on diclofenac sodium has been proven.


Державна фармакопея України: в 3-х т. / Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів». – 2-е вид. – Х.: Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів», 2015. – Т. 1. – 1128 с.

Довідник лікарських засобів, зареєстрованих в Україні [Електронний ресурс]. – Режим доступу: https://

Каратеев А.Е., Насонов Е.Л., Яхно Н.Н. и др. // Современная ревматол. – 2015. – №1. – С. 4-23.

Симонян А.В., Яковлева Н.И. // Вестник ВолгГМУ. – 2015. – Вып. 4(56). – С. 102-104.

Степанова Э.Ф., Саенко А.Ю., Петров А.Ю. и др. // Фундаментальные исследования. – 2013. – №10-12. – С. 2710-2714.

Baraf H.S., Gloth F.M., Barthel H.R. et al. // Drugs Aging. – 2011. – №28(1). – P. 27-40.

European Pharmacopoeia. – 8-th ed. – Strasbourg: European Directorate for the Quality of Medicines, Council of Europe, 2013. – 3655 p.

Harirforoosh S., Asghar W., Jamali F. // J. Pharm. Pharm. Sci. – 2013. – №16(5). – P. 821-847.

Moiseev O.O., Dorovskoi O.V., Khanin V.A. et al. // Вісник фармації. – 2013. – №4. – С. 19-22.

The United State Pharmacopeia: 37 – NF32. – Rockville: The United State Pharmacopeia, Inc., 2014. – 3503 p.






Technology of Medicines