Stability Indicating Reverse Phase-HPLC Method for the Estimation of Doxorubicin in Bulk and Pharmaceutical Dosage Forms

Abstract

The current research goal was to develop a novel specific method for the
quantitation of the Doxorubicin. The method development was done by using a High-
Performance Liquid Chromatography (HPLC). The extensive method development was
conducted to identify a right combination of chromatographic conditions and validated as
per the regulatory guidelines. The current method overcome the disadvantages of complex
sample preparation, long runtime and improved peak shape. The simple combination of
organic modifier and buffer (40:60) used to elute the Doxorubicin in isocratic mode. The
shorter run time of the method was achieved by optimizing the flow rate of 0.8mL per
minute along with L1-octadecyl chemistry column. The doxorubicin peak was detected by
using a sensitive Ultra violet detector at 254nm. The method was completely wetted with
all the key validation parameters likewise suitability, precision, selectivity, linearity,
robustness and recovery. The purity threshold of more than 990 proves that the method is
free from any possible interferences and the linearity was established at 5 different levels
with a correlation coefficient 0.999. The overall %RSD (relative standard deviation) of
mean recovery was 1.1%. The marketed commercial formulation of Doxorubicin injection
was tested on the developed method to confirm the suitability of the method for both bulk
active substance and pharmaceutical formulations. Based on the experimental outcome
method can be regarded as inventive, short run time, specific to quantitate Doxorubicin.