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Original Articles

DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING LC METHOD FOR THE DETERMINATION OF DOMPERIDONE, SORBIC ACID, AND PROPYLPARABEN IN PHARMACEUTICAL FORMULATIONS

Pages 1802-1813 | Published online: 04 Dec 2010
 

Abstract

A simple, selective, and sensitive stability-indicating LC method has been developed and validated for the simultaneous determination of sorbic acid, propylparaben, and domperidone in pharmaceutical oral suspension formulations. The separations was achieved on a Lichrosorb C8, 150 mm × 4.6 mm and 5 μm column with detection of 280 nm using an isocratic mobile phase mixture of phosphate buffer (0.05 M) and methanol (40:60 v/v) at flow rate of 1.0 mL/min. Under these conditions, separation of the three components was achieved in less than 10 min. The retention times for sordid acid, propylparaben, and domperidone were found to be 3.88, 6.12, and 8.53 min with good resolution of 7.90 and 6.11, respectively. The calibration curve for sorbic acid, propylparaben, and domperidone was linear in the range of 30–150, 5–30, and 36–180 μg/mL, respectively with r = ≥0.9998 for each component. The proposed method was successfully employed for quantification of sorbic acid, propylparaben, and domperidone in pharmaceutical formulations.

Notes

*Mean of three replicate.

*Mean of three replicate.

n = 3 determinations, data for SA, PP, and DP, respectively.

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