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Simultaneous determination and stability indicating HPLC assay method for cefatrizine pentahydrate and potassium clavulanate

Singh Loveraj, Gupta Pallavi, Kona.S.Srinivas, Dwivedi Dhananjay, Kishor Kamal

A rapid and specific high-performance liquid chromatographic gradient method was developed and validated for the simultaneous determination of cefatrizine and potassium clavulanate in bulk drug. The present paper describes the simultaneously determination and stability-indicating assay method byHPLC. Forced degradation studieswere performed for cefatrizine pentahydrate and potassium clavulanate bulk drug using acid (0.1N hydrochloric acid), base (0.01N sodium hydroxide), and oxidation (0.1% hydrogen peroxide). Chromatography conditions were phosphate buffer pH 5.5 (20mM potassium dihydrogen orthophosphate), acetonitrile, orthophosphoric acid and triethylamine.The mobile phase initial composition was (buffer: acetonitrile- 100:0).A(150ï‚´4.6mm)Kromasil columnwith particle size 5µm was used. The flow rate was 1ml/min, the column temperature was 30ï‚°C, and the detection performed out a wavelength of 210nm. The samples were kept at 5ï‚°C in an autosampler cooler. The developed HPLC method was statistically validated and method was linear, précised, rugged and robust.