Determination of MPEG-DSPE and HSPC in doxorubicin hydrochloride liposome injection by HPLC-ELSD / 中国药学杂志

ABSTRACT

OBJECTIVE: To develop an HPLC-ELSD method for determination of MPEG-DSPE and HSPC in doxorubicin hydrochloride liposome injection. METHODS: The column was Waters Symmetry 300 C18(4.6 mm × 150 mm, 5 μm; pore size; 300 Å). The mobile phase was methonal-tetrahydrofuran-0.17 mol · L-1 ammonium acetate(93: 6:1). The flow rate was 1.0 mL · min-1. The column temperature was 25℃ and the injection volume was 10 μL. The ELSD conditions were as follows: Alltech 2000ES ELSD detector; drift temperature; 110℃; rate; 2.6 L · min-1. RESULTS: This method had good specificity. The linear ranges of the calibration curves for MPEG-DSPE and HSPC were 0.03-0.48 mg · mL-1 (r=0.999 8) and 0.1-1.0 mg · mL-1 (r=0.9998), respectively. The average recovery rates of MPEG-DSPE and HSPC were 100.0% (n=3 × 3) and 101.0% (n=3 × 3), respectively. The LODs of MPEG-DSPE and HSPC were 13 and 52 ng, respectively. The repeatability and intermediate precision of MPEG-DSPE were 0.9% (n=5) and ≤1.9% (n=3), respectively. The repeatability and intermediate precision of HSPC were 1.1% (n=5) and ≤1.3%(n=3), respectively. CONCLUSION: The established method is accurate, reliable, repeatable and suitable for the determination of MPEG-DSPE and HSPC in doxorubicin hydrochloride liposome injection.