Analytical Method Development And Validation Of Cromolyn Sodium By Rp-Hplc Technique

A simple, précised, accurate method was developed for the estimation of cromolyn sodium by
reverse phase high performance liquid chromatography technique. Chromatographic conditions
used are stationary phase is, agilent zorbax stable bond aqueous (250 x 4.6mm, 5µ). Diluents are,
50% 0.1% perchloric acid: 50% acetonitrile and detection wave length was 272 nm, column
temperature was set to 30°c and diluents were methanol: water (50:50), conditions were finalized
as optimized method. System suitability parameters were studied by injecting the standard five
times and results were well under the acceptance criteria.
The mean absolute recovery of cromolyn sodium was the recovery of first level was 99.64%, for
second level 99.75% and for third level 100.17%. The drug shows linearity in the range of 40 -60
µg/ml for chromatography respectively and r2 value was found to be as 0.9999. Limit of
detection is equal to 3.3σ/$ which is found as 2.52 and limit of quantitation is equal to10σ / $
which is found as 7.64. The proposed method offers distinct advantage in simplicity and
sensitivity and could be easily used in quality control laboratory for the analysis of cromolyn
sodium in its bulk powder.