Quantification of Soluplus for Dissolution Tests: SEC Method Development and Validation

The quantification of both polymer and drug during the dissolution of an amorphous solid dispersion (ASD) in aqueous media arouses great interest and may aid in the formulation. However, the available quantification methods for polymer excipients are limited, expensive, and challenging compared to drugs. In this work, a size exclusion chromatography method (HPLC-SEC) was developed and validated to determine the concentration of a frequently used polymer excipient, Soluplus® (Sol).

In order to develop a method for the quantification of dissolved Soluplus®, two methods (SEC-UV and SEC-RID) with two injection volumes were tested with standard solutions of three different batches of Soluplus. The developed HPLC-SEC-UV method showed acceptable linearity (R² > 0.9990) for all batches of Soluplus, good accuracies above a concentration of 0.1 mg/mL (coefficient of variation < 2%), relatively good precision at a concentration of 0.1 mg/mL (coefficient of variation < 2.5%), and high recoveries at a concentration of 0.75 mg/mL (coefficient of variation < 0.5%).

The presence of Felodipine (Fel) and Lumefantrine (Lum) in the liquid media did not interfere with Soluplus quantification. The use of various surfactants, such as Tween® 80, Tween® 20, Span® 80, Span® 20, Kolliphor® TPGS, and sodium lauryl sulphate at a low concentration (0.005 mg/mL) did not show any effect on Soluplus® and did not interfere with Soluplus® quantification with any of the Soluplus batches. The addition of lithium bromide (LiBr) to the mobile phase within a concentration range of 0.05 to 1.0 M did not improve Soluplus® quantification.

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Materials

Methanol (≥99.9 %) was supplied by Honeywell Chromasolv (Seelze, Germany). Uracil (≥99 %) was supplied by Sigma-Aldrich (Schnelldorf, Germany). BEH 200 SEC Test Mix was provided by Waters Corporation (Milford, USA). Sodium dihydrogen phosphate dihydrate (≥98 %) and disodium hydrogen phosphate dihydrate (≥98 %) were supplied by Carl Roth GmbH & Co. KG (Karlsruhe-Mühlburg, Germany) and PanReac AppliChem GmbH ITW Reagents (Darmstadt, Germany), respectively. Three batches of Soluplus® were provided by BASF SE.

Zoltán Márk Horváth, Liga Lauberte, Valentyn Mohylyuk, Quantification of Soluplus for Dissolution Tests: SEC Method Development and Validation, Journal of Pharmaceutical Sciences, 2024, ISSN 0022-3549, https://doi.org/10.1016/j.xphs.2024.06.023.

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