The Stability Testing Program was designed to assess the stability of chloramphenicol in 1 ear drop and 7 eye drops of marketed products. The degradation of chloramphenicol in all formulations was found to be first order. The reaction rate at 70, 60, and 50 ?C of each product was correlated to temperature in Arrhenius relationship. The heat of activation of the ear was found to be 14.7 kcal/mole and of the 7 eye drops fall in the range of 20-22 kcal/mole. The predicted degradation rate at 33?C obtained from Arrhenius plot and the actual rate at room temperature storage (30-35?C) were not difference in the range of standard deviation but the predicted rate at 8?C. The shelf-life (t110-90% LA.) of each product at room temperature, which was calculated from predicted rate and actual rate, was not difference in the range of standard deviation. The shelf-life of the ear-drop preparation was 3.45 and 3.00 (2.34-4.19) month respectively. The shelf-life of the 7 eye-drop preparations was predicted to be 1.72 to 3.06 month, average 2.47 +- 0.47 month and the actual shelf-life of the 7 eye-drop preparations was found to be in the range of 1.54 to 3.67 month, average 2.52 +- 0.85 month. Conclusively shelf-life of chloramphenicol eye drops at room temperature (33?C) was found to be about 2.5 month which is shorter than the shelf-life specified by BPC 1973 as 4 month at 25?C.The predicted shelf-life at 8?C and the actual in refrigerator of the ear-drop preparation were not difference in the range of standard deviation which were found to be 25.75 month and 27.53 (10.81-50.29) month respectively. However the shelf-life of 7 eye-drop preparations was significant difference. The predicted shelf-life of 7 eye-drop preparations was found to be in the range of 27.91 to 80.34 month, average 54.38+- 18.08 month and the actual shelf-life was 1.75 to 3.27 month, average 2.07+- 0.61 month. Both the predicted and actual shelf-life differed from the shelf-life specified by BPC 1973 as 18 month at 2-8?C. This Accelerated Stability Testing Program is found to be very useful and handy method for accurately and rapidly predicting the shelf-life of chloramphenicol ear and eye drops at room temperature.
