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<p>Doxorubicin (DOX) and Docetaxel (DTX) are commonly being employed and investigated in combination therapy against cancer, however, there does not exist a validated method to simultaneously analyse these two drugs. To address this gap, a simple, rapid, and sensitive reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of DOX and DTX. The optimized separation was achieved using a C18 column employing an isocratic mobile phase comprising of acetonitrile and octane sulphonic acid buffer (25:75 v/v) with a flow rate of 1&#xa0;mL/min. The detection was carried out at 230 and 240&#xa0;nm with DTX and DOX at retention times of 3.4&#xa0;min and 7.9&#xa0;min, respectively, with a total analysis duration below 10&#xa0;min ideal for formulation development and research purposes. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 67.96&#xa0;ng/mL and 277.86&#xa0;ng/mL for DOX and 65.78&#xa0;ng/mL and 268.84&#xa0;ng/mL for DTX, respectively. The recoveries were within the range of 98–102% ascertaining the accuracy and precision of the method. The developed approach was used to evaluate forced degradation, matrix impact, and assay&#xa0;experiments in acid, base, oxidative, light and temperature-induced stress environment considering its applicability in formulation development. All the applicability studies conducted proved that the method is capable of estimating both drugs distinctively and specifically in these applications. It can be used to fulfil the unmet need for a validated analytical toolset required for industrial and research applications.</p> Graphical Abstract <p></p>

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Highly sensitive validated RP-HPLC–DAD method for simultaneous quantification of doxorubicin and docetaxel: augmenting industrial application

  • 期刊论文

  • 发表日期：

    2025年6月17日

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  • Amrendra Tiwari,
  • Pavan K. Yadav,
  • Aarti Abhishek Shah,
  • Keerti Mishra,
  • Rafquat Rana,
  • Pooja Yadav,
  • Shourya Tripathi,
  • Manish K. Chourasia

摘要

Doxorubicin (DOX) and Docetaxel (DTX) are commonly being employed and investigated in combination therapy against cancer, however, there does not exist a validated method to simultaneously analyse these two drugs. To address this gap, a simple, rapid, and sensitive reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of DOX and DTX. The optimized separation was achieved using a C18 column employing an isocratic mobile phase comprising of acetonitrile and octane sulphonic acid buffer (25:75 v/v) with a flow rate of 1 mL/min. The detection was carried out at 230 and 240 nm with DTX and DOX at retention times of 3.4 min and 7.9 min, respectively, with a total analysis duration below 10 min ideal for formulation development and research purposes. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 67.96 ng/mL and 277.86 ng/mL for DOX and 65.78 ng/mL and 268.84 ng/mL for DTX, respectively. The recoveries were within the range of 98–102% ascertaining the accuracy and precision of the method. The developed approach was used to evaluate forced degradation, matrix impact, and assay experiments in acid, base, oxidative, light and temperature-induced stress environment considering its applicability in formulation development. All the applicability studies conducted proved that the method is capable of estimating both drugs distinctively and specifically in these applications. It can be used to fulfil the unmet need for a validated analytical toolset required for industrial and research applications.

Graphical Abstract