Simultaneous estimation of paclitaxel and bortezomib via LC-MS/MS: pharmaceutical and pharmacokinetic applications.

Pavan K Yadav, Saurabh Verma, Divya Chauhan, Pooja Yadav, Amrendra K Tiwari, Ravi Saklani, Deepak Gupta, Rafquat Rana, Aarti Abhishek Shah, Sonia Verma, Kothuri Naresh, Jiaur R Gayen, Manish K Chourasia
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Abstract

Aim & Objective: This study evaluates the potential of combining paclitaxel (PTX) and bortezomib (BTZ) for breast cancer therapy. Materials & Methods: The nanoformulation was optimized via Box-Behnken Design (BBD), with method validation adhering to US-FDA guidelines. Results: Multiple reaction monitoring transitions for PTX, BTZ and internal standard were m/z 855.80→286.60, 366.80→226.00 and 179.80→110.00, respectively. Elution done on C18 Luna column with 0.1% FA in MeOH:10 mM ammonium acetate. The size of nanoformulation was 133.9 ± 1.97 nm, PDI 0.19 ± 0.01 and zeta potential -19.20 ± 1.36 mV. Pharmacokinetics showed higher Cmax for PTX-BTZ-NE (313.75 ± 10.71 ng/ml PTX, 11.92 ± 0.53 ng/ml BTZ) versus free PTX-BTZ (104 ± 13.06 ng/ml PTX, 1.9 ± 0.08 ng/ml BTZ). Conclusion: Future findings will contribute to the treatment of breast cancer using PTX and BTZ.

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通过 LC-MS/MS 同时估算紫杉醇和硼替佐米:制药和药代动力学应用。
目的与目标:本研究评估了紫杉醇(PTX)和硼替佐米(BTZ)联合治疗乳腺癌的潜力。材料与方法:通过盒-贝肯设计(BBD)对纳米制剂进行了优化,并按照美国食品药品管理局的指南进行了方法验证。结果:PTX、BTZ和内标物的多反应监测跃迁分别为m/z 855.80→286.60、366.80→226.00和179.80→110.00。采用 C18 Luna 色谱柱,以 0.1% FA in MeOH:10 mM 乙酸铵溶液洗脱。纳米制剂的尺寸为 133.9 ± 1.97 nm,PDI 为 0.19 ± 0.01,zeta 电位为 -19.20 ± 1.36 mV。药代动力学显示,PTX-BTZ-NE 的 Cmax(313.75 ± 10.71 ng/ml PTX,11.92 ± 0.53 ng/ml BTZ)高于游离 PTX-BTZ(104 ± 13.06 ng/ml PTX,1.9 ± 0.08 ng/ml BTZ)。结论未来的研究结果将有助于使用 PTX 和 BTZ 治疗乳腺癌。
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