Optimization of HPLC-FLD Conditions Using Analytical Quality by Design Approach for Quantification of Silodosin in Pharmaceutical Dosage Form

Year 2021, Volume: 14 Issue: 3, 993 - 1005, 18.12.2021

Mehmet Emrah Yaman , Tuğrul Çağrı Akman

https://doi.org/10.18185/erzifbed.955967

Cited By: 1

Abstract

An HPLC-FLD method was developed using a surface response methodology for the quantification of silodosin in pharmaceuticals. The HPLC-FLD method was validated for accuracy, precision, working range, reproducibility, the limit of detection, the limit of quantification, and robustness. Analytical Quality by Design (AQbD) strategy was applied to develop an HPLC-FLD method for the quantification of silodosin in pharmaceuticals by using a central composite design methodology. Excitation and emission wavelengths with the highest fluorescence response for silodosin were determined by spectrofluorometric measurements at 256 nm and 456 nm, respectively. The parameters that have an impact on chromatographic separation and detection of silodosin were selected as pH, column temperature, and organic content of the mobile phase (acetonitrile %). A quadratic three-factor central composite design model consisting of 20 observations was used. The method showed good recovery and accuracy. The method was linear in the range of 0.1–40 µg/mL, with a high correlation coefficient (0.9991) and acceptable precision (RSD<7.8%). After validation studies, the optimized method was successfully applied in the analysis of silodosin-containing tablet formulation. The results demonstrated the robustness of the analytical method under the specified conditions. An HPLC-FLD method optimized for statistical tools was developed for analysis on silodosin pharmaceutical products. Using the AQbD approach has provided advantages in terms of time consumption and costs. The resulting method is fast with low analysis time and quite sensitive. We believe that the parameters optimized by the AQbD approach provide reliable conditions for the HPLC-FLD analysis of silodosin.

Keywords

Silodosin, analytical quality by design approach, central composite design, fluorescence detection, pharmaceutical analysis

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