Validated Stability Indicating HPLC Method for Determination of the Polyanionic Cromolyn Sodiumi in Presence of its Alkaline Degradate

Author(s): El-Kosasy AM, Omar AA, Magdy N and El Zahar NM

A simple precise accurate reversed phase HPLC method was presented for the quantitative determination of Cromolyn sodium in pure form, in combined pharmaceutical formulations and in presence of its alkaline degradate. The compounds were eluted isocratically on a C18 column and Cromolyn sodium was quantitatively determined at 235 nm. The mobile phase composed of acetonitrile: water (70: 30, v/v) at flow rate of 1.0 mL/ min. The total run time is 9 min. The standard curve of Cromolyn sodium was over the range of 1 to 100 µg/mL with a limit of quantitation (LOQ) of 30 ng/mL. The validity of the proposed method was assessed using the standard addition technique. The obtained results were statistically compared with those obtained by the official method, showing no significant difference with respect to accuracy and precision at p=0.05

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