Development of a stability-indicating high performance liquid chromatography method for assay of erythromycin ethylsuccinate in powder for oral suspension dosage form

Abstract

In this study an effective method was developed to assay erythromycin ethylsuccinate for an oral suspension dosage form. The chromatographic separation was achieved on an X-Terra[superscript ™] C[subscript 18] analytical column. A mixture of acetonitrile–ammonium dihydrogen phosphate buffer (0.025 mol L[superscript -1]) (60:40, V/V) (pH 7.0) was used as the mobile phase, effluent flow rate monitored at 1.0 mL min[superscript −1], and UV detection at 205 nm. In forced degradation studies, the effects of acid, base, oxidation, UV light and temperature were investigated showing no interference in the peak of drug. The proposed method was validated in terms of specificity, linearity, robustness, precision and accuracy. The method was linear at concentrations ranging from 400 to 600 μg mL[superscript −1], precise (intra- and inter-day relative standard deviations <0.65), accurate (mean recovery; 99.5%). The impurities and degradation products of erythromycin ethylsuccinate were selectively determined with good resolution in both the raw material and the final suspension forms. The method could be useful for both routine analytical and quality control assays of erythromycin ethylsuccinate in commercial powder for an oral suspension dosage form and it could be a very powerful tool to investigate the chemical stability of erythromycin ethylsuccinate.