Variability in the content of Indian generic ciprofloxacin eye drops.

BACKGROUND/AIMS Under-potent generic antibiotics sold in developing world countries may be contributing to positive selection of resistance organisms and to unpredictability in clinical outcome, leading to a loss of confidence among physicians locally. The objective of this study was to determine whether reports of unpredictable outcome for generic ciprofloxacin antibiotic eye drops in India could be the result of inadequate concentration of preparations sold by pharmacies. METHODS 130 ciprofloxacin eye drop samples sold by pharmacies were collected from seven locations in north, central, and south India; 30 were randomly selected for testing. All samples were assayed using validated methods of reverse phase chromatography and fluorescence detection at a international antibiotic reference laboratory in the United Kingdom. Results were compared with advertised concentrations within the context of internationally accepted variability ranges. RESULTS In total, six out of the 30 samples tested had ciprofloxacin concentrations lower than the standard advisory ranges of plus or minus 5% of stated content for 3 mg/ml pharmaceutical preparations. The ciprofloxacin content of these eye drops ranged from -36.4% to -16.1% of the stated content (median -21.73%). 24 out of 30 samples were found to be over the standard advisory ranges of plus or minus 5%, at a median of +19.42% (interquartile range (IQR) +14.28 to +25.13). Intra-batch variability of two selected samples was wide at -22.83% to +33.93% (n=11) and -17.07% to +31.20% (n=12). CONCLUSIONS Approximately 20% of generic ciprofloxacin eye drops, purchased without prescription in India were under-potent. In a number of preparations the antibiotic content was sufficiently low as to have a potential impact on clinical outcome and possibly lead to the selection of resistant isolates in individual patients. More widespread studies are justified to identify the extent of under-potency of widely used generic antibiotic medications in developing countries.