HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC DETERMINATION OF BENZALKONIUMCHLORIDE IN VASOCIDIN(R) OPHTHALMIC SOLUTION

A high-performance liquid chromatographic (HPLC) procedure employing U V detection for the analysis of benzalkonium chloride (BAK) in Vasocid in(R) ophthalmic solution is reported. The method requires no sample p retreatment and is sensitive, accurate, and reproducible. The peak are a versus BAK concentration is linear over the range of 50-150% of its label claim in Vasocidin(R). The mean absolute recovery of BAK using t he described method is 101.3 +/- 2.16%, (mean +/- SD, n = 10). A stres s study with heat, acid, base and UV radiation indicates that the meth od is stability-indicating with no interference from drugs, excipients or their degradation products.