Key result
HPLC methods successfully separate and quantify doxorubicin mixtures with high accuracy and precision.
The study developed and validated HPLC methods for the simultaneous determination of doxorubicin with morphine, granisetron, or cyclophosphamide in 0.9% sodium chloride injection.
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Validated HPLC assays enable doxorubicin admixture analysis; extends analytical capabilities but should not yet alter clinical compounding practices.
High performance liquid chromatographic methods have been developed for the assays of mixtures containing doxorubicin-morphine, doxorubicin-granisetron, and doxorubicin-cyclophosphamide in 0.9% sodium chloride injection USP. The separation and quantitation of each mixture were achieved on octylsilane columns at ambient temperature using a mobile phase of aqueous sodium dihydrogen phosphate - acetonitrile at a flow rate of 1.0 mL/min with UV detection. The separations were achieved within 13 min. The methods showed linearity for the analytes in their respective calibration ranges. Accuracy and precision were in the 0.1–3.3% and 0.2–3.1% ranges, respectively, for the various analytes.
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Zhang et al. (1998) studied this question. HPLC methods for doxorubicin mixtures was evaluated on Separation and quantitation of doxorubicin mixtures. HPLC methods were successfully developed for the separation and quantitation of doxorubicin mixed with morphine, granisetron, or cyclophosphamide, with accuracy and precision in the 0.1-3.3% range.
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