Abstract

A simple, rapid, accurate, specific and sensitive reverse phase-HPLC method has been developed and validated for the estimation of Isotretinoin(ISO) and Erythromycin(ERY) in bulk drug and pharmaceutical dosage form. The chromatographic separation was performed on C18 Column using a mobile phase of Methanol & Phosphate Buffer pH6 (60:40 v/v), at a flow rate of 1ml/min at an ambient temperature with the detection wavelength at 231nm. The retention times of ISO & ERY were 1.69min and 2.8min respectively. The linearity was performed in the concentration range of 10-60μg/ml for ISO and 100-600μg/ml for ERY with a correlation coefficient of 0.995 and 0.994 for ISO & ERY respectively. The proposed method was then validated for different parameters as per the ICH guidelines. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantification and robustness. The results of all the validation parameters were well within their acceptance values. The proposed method was successfully applied for the quantitative determination of Isotretinoin and Erythromycin. Thus the developed method was successfully employed for routine quality control analysis in the bulk dosage forms.