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Related Concept Videos

Data Validation01:15

Data Validation

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Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
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Quantification of soluplus for dissolution tests: SEC method development and validation.

Zoltán Márk Horváth1, Liga Petersone1, Valentyn Mohylyuk1

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|July 7, 2024
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A new HPLC-SEC-UV method accurately quantifies Soluplus® polymer excipient in amorphous solid dispersions. This method is unaffected by common drugs and surfactants, simplifying formulation development.

Keywords:
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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Materials Science

Background:

  • Quantifying polymer excipients during amorphous solid dispersion (ASD) dissolution is crucial for formulation but challenging.
  • Existing methods for polymer quantification are limited, costly, and complex compared to drug analysis.

Purpose of the Study:

  • To develop and validate a size exclusion chromatography (SEC) method for quantifying Soluplus®, a common polymer excipient.
  • To assess the interference of model drugs (Felodipine, Lumefantrine) and surfactants on Soluplus® quantification.

Main Methods:

  • Developed and validated a high-performance liquid chromatography-size exclusion chromatography with UV detection (HPLC-SEC-UV) method.
  • Tested two detection methods (SEC-UV and SEC-RID) and two injection volumes using standard Soluplus® solutions.
  • Investigated the impact of Felodipine, Lumefantrine, various surfactants, and lithium bromide on the quantification.

Main Results:

  • The HPLC-SEC-UV method demonstrated excellent linearity (R² > 0.9990) and accuracy (>0.1 mg/mL, CV < 2%).
  • Good precision (CV < 2.5%) and high recoveries (CV < 0.5%) were achieved at relevant concentrations.
  • Quantification of Soluplus® was not affected by the presence of Felodipine, Lumefantrine, or common surfactants at 0.005 mg/mL.

Conclusions:

  • A validated HPLC-SEC-UV method provides a reliable and accessible means for quantifying Soluplus® in dissolution studies.
  • The method's robustness against common formulation components simplifies its application in ASD development.
  • This advancement facilitates better understanding and optimization of ASD formulations.