Effect of Sunlight, Moisture, Temperature and Ultraviolet Radiation on the Quality Control Parameters of Ciprofloxacin Tablet Formulation

Abstract

This work assesses the stability and quality of Ciprofloxacin hydrochloride tablets after subjection to accelerated stability conditions of sunlight, temperature of 40±1 0 C, 75% relative humidity, and UV light of 365 nm for 4 hours each day. This study was performed at time zero and at 4-day intervals for a period of 45 days (that is, days 0, 4, 8, 12…40, 44) according to the International Conference on Harmonization (ICH) accelerated aging conditions and the results obtained were subjected to statistical analysis. The results showed that with increasing time there was a gradual reduction in the dissolution rate with the tablets exposed to all four storage conditions failing the test on day 44 where they had less than 80 % release of the label claim. For content of Ciprofloxacin Hydrochloride, only those tablets exposed to UV light passed the test for all 44 days as they had a minimum of 96.83 % content on the 44 th day. At day 0, all the tablets assayed passed this test, having a ciprofloxacin content of 99.43 %. For those tablets subjected to the other storage conditions including temperature of 40±1 0 C, 75 % relative humidity and sunlight, they had ciprofloxacin content of 70.22 %, 71.50 %, and 78.36 % respectively. The results further, indicated that the storage conditions used in the study had a greater impact on the dissolution behavior and content of the Ciprofloxacin tablets than they did on the physical stability (hardness, uniformity of weight, disintegration).