He Bingfang
2010
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Journal
Chinese Journal of Pharmaceuticals
Abstract
An HPLC method was established for the determination of the related substances—4-aminobenzoic acid and 4-(butylamino) benzoic acid in tetracaine hydrochloride.A C18 column was used with the mobile phase of 0.01 mol/L sodium dihydrogen phosphate solution (containing 20 mmol/L sodium dodecylsulphate,adjusted to pH 3.0 by phosphoric acid) -methanol(25:75) at the detection wavelength of 280 nm.No 4-Aminobenzoic acid was found,the contents of 4-(butylamino) benzoic acid and total related substances were less than 0.4% and 1.0%.