Objective: To establish a reciprocating cylinder method for the dissolution test of rabeprazole sodium enteric-coated tables and compare the dissolution behaviors of rabeprazole sodium enteric-coated tables from different manufacturers. Methods: Through the screening and investigation of the key test conditions such as reciprocating frequency and screen aperture, the reciprocating cylinder apparatus test method was established. The temperature was 37 ℃, the frequency of repetition was 10 dip · min-1, the immersion time was 10 s, the drip time was 20 s, the upper screen was 20 mesh, the lower screen was 40 mesh, and with 250 mL pH 8.0 tris hydrochloride buffer, pH 7.4 phosphate buffer and pH 6.8 phosphate buffer as the dissolution medium. The dissolution profiles of rabeprazole sodium enteric-coated tables from different pharmaceutical manufacturers were determined by using the newly established reciprocating cylinder method and the dissolution conditions of paddle method specified in Chinese Pharmacopoeia and the dissolution curves of consistency were evaluated by calculating the similarity factor. Results: While using paddle method the dissolution profiles of the two domestic pharmaceutical manufacturers were similar to those of the reference listed drug (f2>50). While using reciprocating cylinder method the dissolution profiles of the two domestic pharmaceutical manufacturers were similar only under the conditions of pH 8.0 and pH 7.4, and the other conditions were not similar. Conclusion: This method can be used to determine the dissolution of rabeprazole sodium enteric-coated tablets with a certain resolution. It can provides assistance for further optimizing manufacturing process and evaluating the consistency of generic drugs. This study also provides an idea for the in vitro dissolution study of other active pharmaceutical ingredients readily degradable preparations.
YU Li-ju
,
CHEN Tian-yi
,
LI Yi-na
,
QI Yan-chao
,
NING Bao-ming
. Investigation of in vitro drug dissolution of rabeprazole sodium enteric-coated tablets with reciprocating cylinder method*[J]. Chinese Journal of Pharmaceutical Analysis, 2025
, 45(4)
: 654
-662
.
DOI: 10.16155/j.0254-1793.2024-0134
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