Preformulation Studies for Generic Omeprazole Magnesium Enteric Coated Tablets

Table 6

HPLC assay results for conditions A, B, and C.

Sampled days	Omeprazole alone	Omeprazole: all excipients
Condition: A—room, uncontrolled conditions—30 ± 2°C
Day 0	100	100
Day 7	99.97	99.11
Day 30	99.48	98.93
Day 60	99.23	98.52
Day 90	99.14	98.26
Condition: B—room, controlled conditions—40 ± 2^˚C/75% ± 5%RH
Day 0	100	100
Day 7	98.65	98.23
Day 30	97.40	97.60
Day 60	97.24	97.37
Day 90	96.94	96.95
Condition: C—oven (50°C)
Day 0	100	100
Day 7	97.73	98.39
Day 30	97.10	97.85
Day 60	96.98	97.01
Day 90	96.75	96.68