Abstract

Development and validation of novel stability indicating methods for estimation of amylocaine hydrochloride in bulk and dosage form

Author(s): Hanan Ahmed Merey, Fahima A.Morsy, Mohammed A.Mohammed, Maissa Y.Salem

Three sensitive and selective methods were developed and validated as stability indicating methods for the determination of amylocaine HCl in presence of its degradation product. The first method is based on the use of derivative ratio spectrophotometry (1DD) for the determination of amylocaine HCl in presence of its degradation product and of methyl and propyl parabens by measurement of the peak amplitudes of the first derivative of ratio spectra at 234 and 247 nmusing the spectrum20 µg of total parabens as a divisor. The second method is a spectro-densitometric method for the determination of amylocaine HCl after separation fromits degradation product and additives of pharmaceutical dosage form using toluene: methanol: chloroform: 10%NH3 (5:3:6:0.1 v/v) followed by detection at 234 nm. The third method is an isocratic high performance liquid chromatographicmethod (HPLC) on a reversed phase C18 column usingmobile phase consisting of distilled water: acetonitrile: triethylamine (530: 470: 0.1v/v) and the pH was adjusted to 3 by o-phosphoric acid. The proposed methods were successfully applied for the analysis of amylocaine HCl in laboratory prepared mixtures and in pharmaceutical dosage form and the results obtained were assessed by applying the standard addition technique. Statistical comparison between the results obtained by applying the proposed methods and manufacturer's method for amylocaine HCl in its pure powder form was done and no significant difference was found at p = 0.05.