Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF DIDANOSINE IN TABLET DOSAGE FORM

Israralam A. Shaikh, Padmanabh B. Deshpande* and Sumit Soundale

Abstract

The present work describes development and validation of a new simple, accurate, precise and selective stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method for determination of Didanosine as bulk drug and in tablet dosage form. As stability testing is key step in new drug as well as formulation development, stress degradation studies were performed according to ICH guidelines. Chromatographic resolution of Didanosine and its degradation products was accomplished by use of Jasco HPLC system equipped with Grace C18 column (150 x 4.6 mm i.d.) as stationary phase and mixture comprising of Acetonitrile: Methanol (85: 15, v/v) the pH was adjusted to 8 with triethylamine as optimum mobile phase. Densitometric detection was carried out at 250 nm. The retention time was found to be 2.58 ± 0.04 min. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. Results were linear in the range of 5-30 μg mL-1. The developed method has been successfully applied for the estimation of drug in tablet dosage form.

Keywords: Didanosine, RP-HPLC, Forced degradation, Tablet dosage form.