UPLC Method Optimisation and Validation for the Estimation of Sodium Cromoglycate in Pressurized Metered Dosage Form

Abstract

UPLC assay method optimised and validated for sodium cromoglycate in metered dose inhaler (MDI) using metronidazoleas an internal standard.The separation of Sodium Cromoglycate was achieved on Hypersil BDS C18 (100 mm x 2.1 mm, 1.7 μm) with gradient mobile phase containing methanol, orthophosphoric acid and acetonitrile in the ratio of 50:15:35 %v/v/v. The flow rate was 0.25 mLmin-1, injection volume 20μl and detection wavelength was set at 326nm, at ambient temperature. The validation of the proposed method was carried outfor linearity, accuracy, precision, robustness, limit of detection and limit of quantification test as per ICH guideline. The retention time of sodium cromoglycate found to be 4.73 min. Calibration graph was found to be linear at range 8- 40μg/ml. The regression coefficient (r2) was found tobe 0.9978.The proposed method was rapid with adequate accuracy, precision, ruggedness and robustness and hence be suitable for theroutine analysis of sodium cromoglycate in meter dose inhalation and in bulk.