LC-MS/MS method for simultaneous Doxorubicin and Baicalein estimation: formulation and pharmacokinetic applications.

Pooja Yadav, Sanjay Singh, Divya Chauhan, Pavan Kumar Yadav, Amrendra Kumar Tiwari, Naresh Kothuri, Sonia Verma, Jvus Chakradhar, Mitali Sethi, Jiaur R Gayen, Manish Kumar Chourasia
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Abstract

Aim & objective: Combinatorial delivery of Doxorubicin (DOX) and Baicalein (BAC) has a potential to improve breast cancer treatment by mitigating the cardiotoxicity induced by DOX. The nanoformulation has been optimized and subjected to pharmacokinetic studies using LC-MS/MS.Materials & methods: Nanoformulation bearing DOX and BAC was optimized using quality by design approach and method validation was done following USFDA guidelines.Results: The particle size, PDI and zeta potential of developed nanoformulation were 162.56 ± 2.21 nm, 0.102 ± 0.03 and -16.5 ± 1.21 mV, respectively. DOX-BAC-SNEDDs had a higher AUC0-t values of 6128.84 ± 68.71 and 5896.62 ± 99.31 ng/mL/h as compared with DOX-BAC suspension.Conclusion: These findings hold promise for advancing breast cancer treatment and facilitating therapeutic drug monitoring.

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LC-MS/MS 法同时测定多柔比星和黄芩苷:制剂和药代动力学应用
目的和目标:多柔比星(Doxorubicin,DOX)和黄芩苷(Baicalein,BAC)的联合给药有望减轻 DOX 引起的心脏毒性,从而改善乳腺癌的治疗。已对该纳米制剂进行了优化,并使用 LC-MS/MS 对其进行了药代动力学研究:材料与方法:采用质量设计法对含有 DOX 和 BAC 的纳米制剂进行了优化,并根据 USFDA 指南进行了方法验证:结果:所开发的纳米制剂的粒度、PDI 和 zeta 电位分别为 162.56 ± 2.21 nm、0.102 ± 0.03 和 -16.5 ± 1.21 mV。与 DOX-BAC 悬浮液相比,DOX-BAC-SNEDDs 的 AUC0-t 值更高,分别为 6128.84 ± 68.71 和 5896.62 ± 99.31 ng/mL/h:这些发现有望推动乳腺癌的治疗并促进治疗药物的监测。
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