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Related Concept Videos

Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Quality by Design-Based RP-HPLC Method for Simultaneous Estimation of 4-Hydroxytamoxifen and Thymoquinone in

Pavithra Pradeep Prabhu1, Cynthia Lizzie Lobo2, L B Vishal2

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Summary

A new RP-HPLC method quantifies 4-hydroxytamoxifen and thymoquinone simultaneously in liposomal formulations. This validated analytical approach supports breast cancer combination therapy development and drug delivery system optimization.

Keywords:
4‐hydroxytamoxifenBox–BehnkenRP‐HPLCthymoquinonevalidation

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Drug Delivery Systems

Background:

  • Simultaneous quantification of drugs in combination therapy is essential for optimizing treatment efficacy.
  • 4-Hydroxytamoxifen (4-OHT) and thymoquinone show synergistic effects in breast cancer treatment.
  • A robust analytical method for simultaneous estimation of 4-OHT and thymoquinone in liposomal systems is lacking.

Purpose of the Study:

  • To design, optimize, and validate a reversed-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous quantification of 4-OHT and thymoquinone.
  • To apply an analytical quality by design (AQbD) approach for method development.
  • To evaluate the method's performance in liposomal formulations.

Main Methods:

  • Analytical Target Profile (ATP) definition and risk assessment using an Ishikawa diagram.
  • Method optimization using Box-Behnken Design, identifying critical parameters like mobile phase composition, flow rate, and column temperature.
  • Validation of the RP-HPLC method according to ICH Q2(R1) guidelines.

Main Results:

  • Optimal conditions: 90:10 methanol:aqueous mobile phase, 0.5 mL/min flow rate, 35°C column temperature.
  • Method validation demonstrated high sensitivity (LOD 0.69-0.29 μg/mL), accuracy (95%-105% recovery), and precision (RSD < 2%).
  • Successful application in liposomal formulations, showing high entrapment efficiency and enhanced drug release, permeation, and cellular uptake.

Conclusions:

  • A validated, sensitive, and precise RP-HPLC method for simultaneous quantification of 4-OHT and thymoquinone in liposomal systems was developed.
  • The method supports the optimization of breast cancer combination therapy and liposomal drug delivery.
  • The developed method exhibits excellent green performance, confirmed by Analytical Eco-Scale assessment.