| Biotechnology |
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| Determination of benzalkonium chloride in viscous ophthalmic drops of azithromycin by high-performance liquid chromatography |
| Yan SHEN, Sheng-jie XU, Shi-chun WANG, Jia-sheng TU |
| Department of Pharmaceutics, China Pharmaceutical University, Nanjing 210009, China; Productivity Center of Jiangsu Province, Nanjing 210042, China |
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Abstract A high-performance liquid chromatography (HPLC) system was used in the reversed phase mode for the determination of benzalkonium chloride (BKC) in azithromycin viscous ophthalmic drops. A Venusil-XBP(L)-C18 (150 mm×4.6 mm, 5 μm) column was used at 50 °C. The mobile phase consisted of a mixture of methanol-potassium phosphate (16:5, v/v). Two sample preparation methods were compared. The results suggested that, compared with an extraction procedure, a deproteinization procedure was much quicker and more convenient. Using the deproteinization procedure for sample preparation, calibration curves were linear in the range 5.0~50 μg/ml. The within-day and inter-day coefficients of variation were less than 10%. The average recoveries were determined as 96.70%, 98.52%, and 97.96% at concentrations of 10.0, 30.0, and 50.0 μg/ml, respectively. Variability in precision did not exceed 5%. In conclusion, this HPLC method using a simple sample treatment procedure appears suitable for monitoring BKC content in azithromycin viscous ophthalmic drops.
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Received: 28 August 2009
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