A dual green chromatographic platform for bioanalytical quantification and pharmacokinetic characterization of the
Marco M Z Sharkawi1, Noha H Amin2, Norhan R Mohamed2
1Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmed Hegazy St., Beni-Suef, 62514, Egypt.
Abstract:
Multiple myeloma (MM) is a hematological malignancy associated with high morbidity and mortality. The BBD salvage regimen, consisting of bendamustine (BEN), bortezomib (BOR), and dexamethasone (DEX), has demonstrated efficacy in patients with relapsed or refractory MM. However, no analytical method has been reported for the simultaneous determination of this regimen, and potential pharmacokinetic interactions among its components remain insufficiently explored. In this study, two environmentally friendly, sensitive, and rapid chromatographic methods were developed and validated for the simultaneous quantification of BEN, BOR, and DEX in rat plasma, using sildenafil (SIL) as an internal standard. The methods showed linearity over wide concentration ranges, along with satisfactory accuracy and precision, and were successfully applied to in vivo pharmacokinetic studies following individual and combined administration of the three drugs. The results revealed measurable changes in pharmacokinetic parameters, suggesting potential pharmacokinetic interactions among the components of the BBD regimen. The LC-MS/MS method provided higher sensitivity and selectivity, while the TLC-densitometric method offered a simpler and more environmentally friendly alternative for routine analysis. In addition, the environmental sustainability of the proposed methods was evaluated using multiple greenness assessment tools, confirming their eco-friendly profiles.
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