Stability-indicating assay of sodium cromoglicate in ophthalmic solution using mixed-mode hydrophilic interaction chromatography.
A hydrophilic interaction chromatographic (HILIC) procedure for the quantification of Sodium Cromoglicate (SCG) in ophthalmic solution is developed. Mobile phase consists of ACN and buffer, 86:14 v/v. Atlantis HILIC-Si column, 25 cm x 4.6 mm, is used as stationary phase. Detection is carried out using a variable wavelength UV-Vis detector at 326 nm. Linearity range and percent recoveries for SCG were 50-400 mug/mL and 100.44%, respectively. The SCG HILIC-UV assay was validated according to the International Conference on Harmonization guidelines. The method separates two impurities and degradation products resulting from stress environment. Influence of organic solvent, ionic strength and mobile phase pH on the retention of SCG is studied. The paper provides optimization of polar anionic solute (SCG) on unmodified silica by HILIC. Proposed method can be used as a stability-indicating assay for SGC and can be proved to be beneficial in ESI-MS for enhanced sensitivity.
Ali
Mohammed Shahid
MS
Jamjoom Pharmaceuticals Company Limited, Jeddah, Saudi Arabia. msali26@rediffmail.com
Rafiuddin
Syed
S
Al-Jawi
Dalya Abdullah
DA
Al-Hetari
Yasmin
Y
Ghori
Mohsin Ul Haq
MU
Khatri
Aamer Roshanali
AR
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000032:analysis / Q000737:chemistry / Q000592:standards; D002853:Chromatography, Liquid / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D004205:Cromolyn Sodium / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D004355:Drug Stability; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D009883:Ophthalmic Solutions / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D009994:Osmolar Concentration; D044367:Phase Transition; D012015:Reference Standards; D012680:Sensitivity and Specificity; D012997:Solvents; D021241:Spectrometry, Mass, Electrospray Ionization; D013056:Spectrophotometry, Ultraviolet
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007202:Indicators and Reagents; D009883:Ophthalmic Solutions; D012997:Solvents; D004205:Cromolyn Sodium