title: Monitoring powder blend homogeneity using light-induced fluorescence.
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.
authors.affiliation: Department of Pharmaceutical Sciences, Campbell University, College of Pharmacy & Health Sciences, Buies Creek, North Carolina 27506, USA.
authors.forename: Vineela
authors.initials: V
authors.lastname: Karumanchi
authors.forename: Michael K
authors.initials: MK
authors.lastname: Taylor
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Ely
authors.forename: William C
authors.initials: WC
authors.lastname: Stagner
mesh_terms: D000704:Analysis of Variance; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D005470:Fluorometry / Q000592:standards; D008027:Light; D016014:Linear Models; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000592:standards; D011208:Powders; D011786:Quality Control; D012015:Reference Standards; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D013997:Time Factors
chemical_list: D004364:Pharmaceutical Preparations; D011208:Powders