Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP–HPLC METHOD FOR ESTIMATION OF DAUNORUBICIN - A CHEMOTHERAPIC DRUG IN BULK AND PHARMACEUTICAL FORMULATIONS

Pallapati Suman, Tirukkovalluri Siva Rao*, Kallam Venkata Siva Rama Krishna Reddy

Abstract

Daunorubicin is a chemotherapy medicine used to treat cancer. A simple, sensitive and specific stability indicating high performance liquid chromatographic (HPLC) method for the determination of Daunorubicin was developed and validated by using Kromasil C18 column (250 mm x 4.6 mm, 5μm) using a mixture of methanol and Acetonitrile in the ratio 75:25 (v/v) as a mobile phase and at a flow rate of 1.0mL/min. Quantification was achieved with an UV detector at 254 nm over the concentration range of 5–30μg/mL. The applied HPLC method allowed the separation and quantification of Daunorubicin with good linearity (r2 = 0.999) in the studied concentration range. Limit of detection and limit of quantification were found to be 0.3μg/mL and 1.0μg/mL, respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. Daunorubicin stock solution was subjected to different stress conditions. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed HPLC method. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of Daunorubicin. The method was successfully applied to the estimation of Daunorubicin in tablet dosage form.

Keywords: Daunorubicin, RP-HPLC, forced degradation, Daunotec© - 20mg, Validation.