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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Liang, Xiaoli Mallik, Rangan Choudhury, Dilip Raman, Srividya Grobin, Adam W. |
| Description | Author Affiliation: Mallik R ( Allergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USA. Electronic address: mallik.rangan@gmail.com.); Raman S ( Allergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USA.); Liang X ( Allergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USA.); Grobin AW ( Allergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USA.); Choudhury D ( Allergan Inc., 2525 Dupont Drive, Irvine, CA 92612, USA.) |
| Abstract | A rapid robust reversed-phase UHPLC method has been developed for the analysis of total benzalkonium chloride in preserved drug formulation. A systematic Quality-by-Design (QbD) method development approach using commercial, off the shelf software (Fusion AE(®)) has been used to optimize the column, mobile phases, gradient time, and other HPLC conditions. Total benzalkonium chloride analysis involves simple sample preparation. The method uses gradient elution from an ACE Excel 2 C18-AR column (50mm×2.1mm, 2.0µm particle size), ammonium phosphate buffer (pH 3.3; 10mM) as aqueous mobile phase and methanol/acetonitrile (85/15, v/v) as the organic mobile phase with UV detection at 214nm. Using these conditions, major homologs of the benzalkonium chloride (C12 and C14) have been separated in less than 2.0min. The validation results confirmed that the method is precise, accurate and linear at concentrations ranging from 0.025mg/mL to 0.075mg/mL for total benzalkonium chloride. The recoveries ranged from 99% to 103% at concentrations from 0.025mg/mL to 0.075mg/mL for total benzalkonium chloride. The validation results also confirmed the robustness of the method as predicted by Fusion AE(®). |
| ISSN | 00219673 |
| Volume Number | 1413 |
| e-ISSN | 18733778 |
| Journal | Journal of Chromatography A |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2015-09-25 |
| Publisher Place | Netherlands |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Benzalkonium Compounds Analysis Chromatography, High Pressure Liquid Methods Excipients Acetonitriles Buffers Chemistry, Pharmaceutical Methanol Journal Article Validation Studies Discipline Analytical Chemistry |
| Content Type | Text |
| Resource Type | Article |
| Subject | Organic Chemistry Medicine Analytical Chemistry Biochemistry |
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