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Title: تقييم طريقة كروماتوغرافيا السائل عالية الأداء لتحديد البنزالكونيوم في محلول القاتيفلوكس كلوريد
Authors: فاتن إبراهيم الضاي كرنجة
Keywords: الكيمياء التحليلية
Issue Date: 2020
Publisher: جامعة إفريقيا العالمية
Citation: جامعة أفريقيا العالمية- عمادة الدراسات العليا والبحث العلمي والنشر- كلية العلوم البحتة والتطبيقية- قسم الكيمياء
Abstract: The aim of the present study to develop and validate a simple analytical method for estimation of benzalkonium chloride in Gatiflox )0.3 %( ophthalmic solution according to ICH guidelines. In this study a simple, rapid, accurate, sensitive and specific reverse phase high performance liquid chromatography (RP- HPLC) method was developed and validated for estimation of benzalkonium chloride in gatiflox ophthalmic solution. The chromatographic analysis was achieved using a base deactivated silanol (BDS) C18 (250 mm, 4.6 mm 5µm) column, with isocratic mobile phase of ammonium acetate buffer and acetonitrile (11:90, v/v) respectively, at a flow rate of 1.5 mL/minute, injection volume 40µL, column temperature maintained at 30 ⁰C and detection wavelength of 210 nm. The method is effective to separate four homologs of benzalkonium chloride with good resolution in presence of excipients, gatifloxacin and degradable compounds within eight minutes. The method was linear over a range of 50- 160µg/mL with a correlation coefficient (R2) of 0.9995. The method validation study revealed excellent accuracy, precision, linearity, specificity, limit of detection (LOD) and limit of quantitation (LOQ) of the proposed method. The proposed method is suitable for the determination of benzalkonium chloride in quality control routine analysis.
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