Reversed-phase liquid chromatographic determination of cromolyn sodium in drug substance and select dosage forms.
This study, presented as a technical communication, describes a reversed-phase liquid chromatographic method for select commercial formulations, namely, inhalation solution, nasal solution, capsule and inhalation aerosol. Miscellaneous validation parameters are also discussed.
Ng
L L
LL
U.S. Food and Drug Administration, Rockville, MD 20857.
D000336:Aerosols; D002214:Capsules; D002853:Chromatography, Liquid / Q000379:methods*; D004205:Cromolyn Sodium / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012996:Solutions
D000336:Aerosols; D002214:Capsules; D012996:Solutions; D004205:Cromolyn Sodium