Simultaneous determination of paclitaxel-stearate (PTX-SA)and its bioactive metabolite paclitaxel (PTX)by RP-HPLC

CHENG Dan; CHEN Jianming

doi:10.3969/j.issn.1006-0111.2018.03.007

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Objective To establish a reversed phase high performance liquid chromatography method which couldb be applied to determine the content of paclitaxel stearate(PTX-SA)and its bioactive metabolites paclitaxel(PTX)simultaneously. Methods Diazepam was chosen to be the internal standard and liquid-liquid extraction method was used for the preparation of sample solution with methyl tert-butyl ether. The two compounds were separated on Agilent Eclipse plus C₁₈ column(4.6 mm×250 mm,5 μm) with gradient elution by using mobile phase of acetonitrile(A)-methanol(B)-water(C), the detection wavelength was 227 nm and the column temperature was 30℃. The flow rate was 1 ml/min and the injection volume was 20 μl. Results The standard curve exhibited good linearity within the concentration of PTX-SA from 0.5-250 μg/ml (r=0.997 6) and PTX from 0.05-25 μg/ml (r=0.997 9), meanwhile the LOQ of PTX-SA and PTX were 0.15 and 0.05 μg/ml, respectively. The recoveries were both larger than 90% with RSD less than 5%. Moreover, the RSD of intra-day and inter-day assays were both less than 5%. Conclusion The method was simple, effective, stable and accurate which could be suitable for the determination of PTX-SA and PTX in pharmacokinetic study.

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Simultaneous determination of paclitaxel-stearate (PTX-SA)and its bioactive metabolite paclitaxel (PTX)by RP-HPLC

1. School of Pharmacy, Second Military Medical University, Shanghai 200433, China

2. School of Pharmacy, Second Military Medical University, Shanghai 200433, China;Tasly Group Co. Ltd., Tianjin 300402, China

Received Date: 2017-12-18

Rev Recd Date: 2018-02-28

Key words:

RP-HPLC /
PTX-SA /
PTX /
content determination

Abstract: Objective To establish a reversed phase high performance liquid chromatography method which couldb be applied to determine the content of paclitaxel stearate(PTX-SA)and its bioactive metabolites paclitaxel(PTX)simultaneously. Methods Diazepam was chosen to be the internal standard and liquid-liquid extraction method was used for the preparation of sample solution with methyl tert-butyl ether. The two compounds were separated on Agilent Eclipse plus C₁₈ column(4.6 mm×250 mm,5 μm) with gradient elution by using mobile phase of acetonitrile(A)-methanol(B)-water(C), the detection wavelength was 227 nm and the column temperature was 30℃. The flow rate was 1 ml/min and the injection volume was 20 μl. Results The standard curve exhibited good linearity within the concentration of PTX-SA from 0.5-250 μg/ml (r=0.997 6) and PTX from 0.05-25 μg/ml (r=0.997 9), meanwhile the LOQ of PTX-SA and PTX were 0.15 and 0.05 μg/ml, respectively. The recoveries were both larger than 90% with RSD less than 5%. Moreover, the RSD of intra-day and inter-day assays were both less than 5%. Conclusion The method was simple, effective, stable and accurate which could be suitable for the determination of PTX-SA and PTX in pharmacokinetic study.

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Reference (14)

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Simultaneous determination of paclitaxel-stearate (PTX-SA)and its bioactive metabolite paclitaxel (PTX)by RP-HPLC

doi: 10.3969/j.issn.1006-0111.2018.03.007

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