Development and Validation of a Stability-Indicating Analytical Method for Quantitative Determination of Selected Anticancer Drugs in Pharmaceutical Dosage Form

Abstract

Anticancer drugs are complex, chemically active compounds that are highly potent, and their quality, safety, and effectiveness must be maintained at a high level to ensure usability throughout their shelf life. Various environmental and chemical factors readily degrade the anthracycline anticancer drug Doxorubicin, making it essential to develop a robust analytical technique for stability reporting. In the current research, a simple, specific, and sensitive stability-informing chromatographic methodology for the quantitative determination of doxorubicin in pharmaceutical dosage forms is developed and validated. The optimal chromatographic separation was performed on a reversed-phase high-performance liquid chromatography (RP-HPLC) platform under optimized conditions to enable effective separation of doxorubicin and its degradation products, as well as formulation excipients. The forced degradation data were conducted under acidic, alkaline, oxidative, thermal, photolytic, and hydrolytic conditions to demonstrate the method's stability-indicating capacity. The procedure was tested in accordance with the International Council for Harmonization (ICH) guidelines for specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification. These validation results showed high linearity at the chosen concentration range, high recovery, and acceptable precision. The method developed was stability-indicating and appropriate for conducting regular quality control analysis of doxorubicin in pharmaceutical dosage forms. Moreover, the described methodology can be readily applied to other structurally related anticancer drugs, thereby justifying its further use in pharmaceutical quality control.