STABILITY OF OMEPRAZOLE IN AN EXTEMPORANEOUSLY PREPARED ORAL LIQUID

The stability of omeprazole 2 mg/mL in an extemporaneously prepared or al liquid was studied. The contents of five 20-mg omeprazole capsules were mixed with 50 mL of 8.4% sodium bicarbonate solution in a Luer-Lo k syringe. Three vials of this liquid were prepared for storage at 24, 5, and -20 degrees C. A 3-mL sample of each was taken initially and o n days 1, 2, 3, 4, 6, 8, 10, 12, 14, 18, 22, 26, and 30 and assayed by high-performance liquid chromatography. The liquids stored at 5 degre es C and at -20 degrees C did not change color during the study period , but the color of the liquid stored at 24 degrees C changed from whit e to brown. There were non significant changes in the omeprazole conce ntrations of the liquids stored at 5 and -20 degrees C during the stud y period, but the omeprazole concentration of the liquid stored at 24 degrees C was <90% of the initial concentration on day 18. Omeprazole 2 mg/mL in an oral liquid compounded extemporaneously from capsules an d sodium bicarbonate injection was stable for up to 14 days at 24 degr ees C and for up to 30 days at 5 and -20 degrees C.