Influence of storage conditions on the potency of amoxicillin dispersible tablets stored in hospital and community pharmacies at different regions of Kerala

ABSTRACT

This study was conducted to evaluate the influence of storage conditions on the potency of amoxicillin tablets. Samples were collected at different time intervals from hospital and community pharmacies located in different regions of Kerala. All analytical evaluations according to Indian Pharmacopoeia using UV spectrophotometric method were done in collaboration with Sterling Test House, Cochin. Dissolution studies were performed using distilled water in USP type II apparatus. The temperature was maintained at 37 +/- 0.5 [degree sign] C and the rotation speed was 100 rpm. The samples were withdrawn at various time intervals and analyzed UV spectrophotometrically. Microbiological evaluation of test samples at 10 micro g/ml concentration was performed using E.coli MTCC 443 in nutrient agar medium. The mean kinetic temperature and the humidity of Kerala were provided by meteorological department. Thirubananthapuram. SPSS was used for statistical analysis. There were seasonal fluctuations in the Mean Kinetic Temperature and Mean Kinetic Humidity in study areas of Kerala. The percentage strength of amoxicillin was least in samples from Cochin compared with those from Kozhikode and Kannur. Mean Kinetic humidity was more in coastal area, which may have accelerated the degradation of amoxicillin in samples from Cochin. This influence of humidity was significantly less on samples collected from other centers. Disintegration time was within satisfactory limits, although a slight increase in disintegration time was observed in third sample. Microbiological data showed significant reduction in zone of inhibition for samples collected from Cochin in comparison with other centers. Evaluation made during the study provides significant evidences that the quality of a drug substance or product under the influence of various environmental factors may change with time. Hence the regulatory authorities and pharmaceutical organizations should highlight the importance of maintaining good storage conditions in hospital and community pharmacies functioning in state of Kerala