Stability Study of Non Preservative Dexamethazone Eye Drop Extemporaneous Preparations by High Performance Liquid Chromatography

Abstract

Extemporaneous dexamethazone eye drop, preservative-free formula is necessary for patients with contraindications to use preservatives. The objective of this study is to determine the physical, biological and chemical stability of products when stored at different temperatures. Conducting a Quasi-experimental Research, by dividing thirty ophthalmic solutions keep in refrigerator (2-8^oC) and normal room temperature. Then observed for physical characteristics, acidity and sterility on day 0,7,14,21,30. Study quantity of Dexamethazone by HPLC method on day 0,14,21,30The result found that the products stored in the refrigerator (2-8°C) and normal room temperature (31.5±2.1°C) remained as clear solution, free of sediment, colorless, odorless for 30 days, the average pH on days 0, 7, 14, 21 and 30of the products stored in the refrigerator (2-8°C) and normal room temperature (31.5±2.1°C) are 7.18±0.05, 7.18±0.80, 7.27±0.08, 7.32± 0.08, 7.21±0.05 and 7.28±0.02, 7.43±0.49, 7.28±0.11, 7.37±0.09, 7.38±0.10 respectively with a statistically significant differences on day 30(p-value = 0.007).From sampling inspection method the randomized culture samples was found no growth on 0, 7, 14, 21 and 30 days in both groups.Quantitative analysis  ofDexamethazone  by HPLC showed that the products kept in refrigerator (2-8^oC) passed the standard at 90.0 - 115.0% Labeled amount during the study period. An average  % Label amount in Days 0, 14, 21 and 30 are 104.00±3.61, 101.67±1.15, 102±1.73, 103±7.00 respectively.When the products kept in normal room temperature (31.5±2.1°C)  meet the standards on 0, 14 and 21.The average % Label amount on days 0, 14, 21 are104.±4.73, 105.00±5.57, 99.33±0.58respectively. But on the day 30^th they have 1 ophthalmic bottle containing Dexamethazoneunder the standard of % Labeled amount.It can be concluded that Extemporaneous  dexamethazone eye drop, preservative-free formula has physical, biological and chemical stability in 30 days when stored in the refrigerator (2–8°C) and has physical, biological stability in 30 days, but chemical stability is only 21 days when stored at normal room temperature ( 31.5±2.1°C). That mean the Product has Beyond-Use Date, BUD for 30 days when stored in the refrigerator (2–8°C) and 21 days when stored at normal room temperature ( 31.5±2.1°C). Study for the biological stability of products in the real environment when the patient Spray to use at home is be interesting.