Quantitative determination of sodium stearyl fumarate in a tablet formulation from continuous manufacturing using a high-pH reversed-phase HPLC method |
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Authors: | Xiaoyu Zhang Michele E. Lake Adam S. Butterbaugh Kirk A. VanDer Kamp |
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Affiliation: | Small Molecule Design and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA |
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Abstract: | This study demonstrates the first use of a reversed-phase (RP) high-performance liquid chromatography method with a high-pH buffer for the analysis of sodium stearyl fumarate (SSF) from a tablet formulation. After examining the retention time and peak shape using various buffer concentrations, buffer pH, and RP stationary phases, an optimized method was established using the XBridge® BEH C18 at high pH. This column was further evaluated for method specificity, accuracy, precision, linearity, stability, and sensitivity. Finally, the method was successfully used as a convenient and robust analytical procedure to accurately quantitate SSF in stratified tablets from a continuous manufacturing process to confirm the excipient uniformity throughout the process. |
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Keywords: | Continuous manufacturing high pH HPLC reversed phase sodium stearyl fumarate solubility |
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