Simultaneous Analysis of Dexketoprofen Trometamol and Diclofenac Sodium in Pharmaceutical Samples Using Hplc Method with Diode-Array Detector

Abstract

The aim of this study is to develop a high pressure liquidchromatography (HPLC) method for simultaneousanalysis of dexketoprofen trometamol (DKP) and diclofenac sodium (DIC) which can be used as a combinedformulation of in nonsteroidal anti-inflammatory druggroup in pharmaceutical samples. Seperation was performed on Inertsil C18 reverse phase column systemusing a mobile phase consisting of acetonitrile and pH3.0 0.025 M phosphate buffer (70:30 v/v). Flow ratewas 0.7 mL/min and determinations of DIC and DKPwas performed at 260 nm by using DAD detector. DKPand DIC in pharmaceutical preparation were determined by the developed HPLC method. Pharmaceuticalsamples were analyzed by HPLC without using preliminary seperation step. The obtained results by the procedure of HPLC were accurate, precise, sensitive, selectiveand robust for quantitation analysis of DKP and DIC inpharmaceutical samples

Keywords

• Dexketoprofen Trometamol, Diclofenac Sodium, HPLC, Pharmaceutical Sample

DEKSKETOPROFEN TROMETAMOL VE DİKLOFENAK SODYUM’UN FARMASÖTİK ÖRNEKLERDE DAD DEDEKTÖRLÜ HPLC İLE EŞZAMANLI TAYİNİ

Abstract

Bu çalışmanın amacı, nonsteroidal antienflamatuvarilaç grubunda yer alan, kombinasyon olarak kullanılandeksketoprofen trometamol (DKP) ve diklofenaksodyum’un (DIC) farmasötik örneklerde eş zamanlıanalizi için bir yüksek basınçlı sıvı kromatografisi(HPLC) yöntemi geliştirmektir. Ayırmalar hareketli fazolarak asetonitril: 0.025 M ile pH 3.0 fosfat tamponu(70:30 h/h) karışımı kullanılarak Inertsil C18 ters fazkolon sisteminde yapılmıştır. Akış hızı 0.7 mL/dk’dır.Çalışmalar 260 nm dalga boyunda yapılmıştır. Geliştirilen yeni metot kullanılarak farmasötik preperatlardaDKP ve DIC tayinleri yapılmıştır. Farmasötik örneklerherhangi bir ön ayırma basamağına tabi tutulmadanHPLC’de analiz edilmiştir. HPLC yöntemiyle elde edilenanaliz sonuçlarının farmasötik örneklerde DKP veDIC’in kantitatif analizleri için doğru, kesin, duyarlı,seçici ve sağlam ve tutarlı olduğu görülmüştür

Keywords

• Deksketoprofen Trometamol, Diklofenak Sodyum, HPLC, Farmasötik Örnek

References

1. Kayaalp SÖ, Rasyonel Tedavi Yönünden Tıbbi Farmakoloji, Hacettepe Taş Kitapçılık Limited Şti., Ankara 2005; 1,8: 981.
2. Chandrasekharan NV, Dexketoprofen, xPharm: The Comprehensive Pharmacology Reference 2007; 1-4.
3. Jiménez-Martínez E., Gasco-García C., Arrieta- Blanco JJ et al. Study of the analgesic efficacy of Dexketoprofen Trometamol 25mg. vs. Ibuprofen 600mg. after their administration in patients subjected to oral surgery. Med. Oral 2004; 9: 138-148.
4. Dexketoprofen trometamol, Erişim:[http:// www.chemicalbook.com/Chemical ProductPrope r t y _ E N _ C B 4 8 5 4 9 0 2 . h t m ] , E r i ş i m Tarihi:20.03.2016
5. Guler S, Ertok I, Sahin NY, et al. Anaphylaxis after intravenous infusion of dexketoprofen trometamol. Turk J Emerg Med 2016; 16(3): 132-133.
6. Serri C, de Gennaro B, Quagliariello V, et al. Surface modified zeolite-based granulates for the sustained release of diclofenac sodium. Eur J Pharma Sci 2017; 99: 202–208.
7. Žilnik LF, Jazbinšek A, Hvala A, et al. Solubility of sodium diclofenac in different solvents. Fluid Phase Equilibria 2007; 261: 140-145.
8. Rx Media Pharma İnteraktif İlaç Bilgi Kaynağı, Diklofenak, 2016.

9. Efosa NJ, Kleiner W, Kloas W, et al. Diclofenac can exhibit estrogenic modes of action in male Xenopus laevis, and affects the hypothalamus- pituitary-gonad axis and mating vocalizations. Chemosphere 2017; 173: 69-77.
10. Effervescent formulations comprising dexketoprofen, Patent Yayın No: WO 2013006146 A1, Patent Sahibi: Mahmut BİLGİÇ, Dosya Kabul Tarihi: 14 Mayıs 2015.
11. Arcelloni C, Lanzi R, Pedercini S, et al. High- performance liquid chromatographic determination of diclofenac in human plasma after solid- phase extraction. J Chromatogr B 2001; 763(1-2): 195–200.
12. Asfak V, Mrinalini D, Leena B, et al. Simultaneous determination of diclofenac sodium and rabeprazole sodium in bulk and pharmaceutical dosage form by LC. Chromatographia 2007; 66: 941-943.
13. Barbanoj MJ, Gich I, Artigas R. et al. Pharmacokinetics of dexketoprofen trometamol in healthy volunteers after and repeated oral doses. J Clin Pharmacol 1998; 38: 33-40.
14. Burke D. and Bannister J. Dexketoprofen trometamol in post-operative pain management. Acute Pain 2003; 5: 57-62.
15. Dhaneshwar SR, Jagtap VN. Development and validation of RP-HPLC-PDA method for simultaneous determination of Dexketoprofen and thiocolchicoside in pharmaceutical dosage form. J Pharm Res 2013; 6: 604-608.
16. Salmeron-Garcia A, Lopez-Lopez E, Román E, et al. Development of an LC–DAD method for analysis of dexketoprofen, tramadol and haloperidol. Study of the Stability of mixtures used for patient- controlled analgesia. Chromatographia 2008; 68: 767-772.
17. Serrano-Rodríguez JM, Serrano JM, Rodríguez JM, et al. Pharmacokinetics of the individual enantiomer S-(+)-ketoprofen after intravenous and oral administration in dogs at two dose levels. Res Vet Sci 2013; 96: 523–525.
18. Sweetman BJ. Development and use of the quick acting chiral NSAID dexketoprofen trometamol (keral). Acute Pain 2013; 4: 109-115.
19. Yilmaz B, Kaban S, Akcay BK, et al. Differential pulse voltammetric determination of diclofenac in pharmaceutical preparations and human se- rum. Braz J Pharm Sci 2015; 51(2): 285-294.
20. Nasir F, Iqbal Z, Khan A, et al. Simultaneous determination of timolol maleate, rosuvastatin calcium and diclofenac sodium in pharmaceuticals and physiological fluids using HPLC-UV. J Chromatogr B 2011; 879(30): 3434-3443.