Monitoring Powder Blend Homogeneity Using Light-Induced Fluorescence |
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Authors: | Vineela Karumanchi Michael K Taylor Kevin J Ely William C Stagner |
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Institution: | (1) Department of Pharmaceutical Sciences, Campbell University, College of Pharmacy & Health Sciences, PO Box 1090, Buies Creek, North Carolina 27506, USA;(2) Present address: Nova Southeastern University School of Pharmacy, 3200 University Dr., Fort Lauderdale, Florida 33328, USA;(3) Biodelivery Sciences International, 801 Corporate Center Dr., Raleigh, North Carolina 27607, USA;(4) GlaxoSmithKline, 1011 N. Arendell Ave, Zebulon, North Carolina, USA; |
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Abstract: | Light-induced fluorescence (LIF) was evaluated as a process analytical technology to monitor blend homogeneity and establish
a relationship with high-performance liquid chromatography (HPLC). Secondary aims for this study included a determination
of blend steady-state, acceptable mixing time interval, and mixing end point. Also, identification of potential “dead spots”
in the 124 L intermediate bulk container mixing tote was explored. Individual samples from 13 sample locations were collected
at 0.25, 0.5, 0.75, 1, 2, 5, 10, and 20 min and analyzed using LIF and HPLC. LIF and HPLC methods showed similar mixing profiles.
A coefficient of determination (R
2) of 0.86 (p value < 0.0001) was obtained for a second-degree polynomial bivariate fit of LIF counts by HPLC percent label claim (%LC).
A significant linear relationship was determined between LIF percent relative standard (%RSD) and HPLC %RSD (R
2 = 0.97, p < 0.0001). The LIF steady-state, acceptable mixing time interval, and mixing end point were determined to be 1–20, 2–20,
and 2 min, respectively. The steady-state, acceptable mixing time interval, and mixing end point determined by HPLC were 1–20,
5–10, and 5 min, respectively. The Tukey–Kramer honestly significant difference analysis of HPLC %LC by sample location at
5 and 10 min mixing times showed that there was a statistical difference between the HPLC %LC group means at two blender locations. |
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