Simultaneous Estimation of Cefixime and Dicloxacillin in Bulk and Tablet Formulation by RP-HPLC Method/Sefiksim ve Dikloksasilin'in Ham Madde ve Farmasötik Formülasyonlardan TF-HPLC Yöntemi ile Eszamanli Tayini

Headnote

Simultaneous Estimation of Cefixime and Dicloxacillin in Bulk and Tablet Formulation by RP-HPLC Method

Summary

Present study reports development and validation of simple, economic, selective, precise, and accurate RP high-performance liquid chromatography (RP-HPLC) method for the analysis of cefixime and dicloxacillin in bulk drug and pharmaceutical formulations. The developed method has shown good resolution for cefixime, dicloxacillin and formulation excipients present in tablets. A mixture of 5 mM Phosphate Buffer (pH 5.4 adjusted with ortho-phosphoric acid): acetonitrile: methanol (42: 55: 3 v/v/v) was used to elute the drug component. HPLC analysis of cefixime and dicloxacillin was carried out at a wavelength of 225 nm with flow rate of 1.0 mL min-1. The method was quantitatively evaluated in terms of linearity, precision, accuracy (recovery), selectivity and robustness as per standard guidelines. The method is simple, convenient and suitable for the analysis of cefixime and dicloxacillin in bulk and pharmaceutical formulations.

Key Words: Reverse-phase HPLC, Cefixime, Dicloxacillin, ICH guidelines.

Sefiksim ve Dikloksasilin'in Ham Madde ve Farmasötik Formülasyonlardan TF-HPLC Yöntemi ile Eszamanli Tayini

Özet

Bu çalismada sefiksim ve dikloksasilin'in farmasötik formülasyonlar ve ham madde olarak ters faz yüksek performansli sivi kromatografisi yöntemi ile basit, ekonomik, seçici, tam ve dogru analiz edilmesine yönelik analitik yöntem gelistirilmesi ve validasyonu raporlanmistir. Gelistirilen bu yöntemde, sefiksim, dikloksasilin ve tabletler içerisinde yer alan diger eksipiyanlar için iyi resolüsyon göstermektedir. Etkin maddeleri elüe etmek için 5 mM fosfat tamponu (orto-fosforik asit ile pH 5.4'e ayarlanmis):asetonitril: metanol (42: 55: 3; h/h/h) karisimi kullanilmistir. Sefiksim ve dikloksasilin'in HPLC analizi 225 nm dalga boyunda 1.0 mL dk-1 akis hizinda gerçeklestirilmistir. Standart rehberler dogrultusunda yöntem dogrusallik, kesinlik, dogruluk (geri kazanim), seçicilik ve saglamlik bakimindan kantitatif olarak degerlendirilmistir. Yöntem, sefiksim ve dikloksasilin'in ham madde ve farmasötik formülasyonlardan tayini açisindan basit, elverisli ve uygulanabilirdir. .

Anahtar Kelimeler: Ters-faz HPLC, Sefiksim, Dikloksasilin, ICH rehberleri

Received: 01.07.2014

Revised: 22.07.2014

Accepted: 20.08.2014

INTRODUCTION

Cefixime, (6R,7R)-7-[2-(2-amino-4-thiazolyl) glyoxylamido] -8-oxo3-vinyl-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid (CFX) is a third generation cephalosporin antibiotic. CFX has broad and potent activities against various pathogens especially gram negative organisms. CFX is given orally in the treatment of susceptible infections including gonorrhea, otitis media, pharyngitis, lower respiratory tract infection and urinary tract infection (1,2). Dicloxacillin, (2S,5R,6R)-6-{[3-(2,6-dichlorophenyl) -5-methyl-oxazole-4-carbonyl] amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid (DLX) is used to treat infections caused by susceptible gram-positive...