OPTIMIZATION AND VALIDATION OF REVERSE PHASE LIQUID CHROMATOGRAPHIC METHOD FOR ESTIMATION OF CETIRIZINE MANNITOL ESTER IMPURITY IN CETIRIZINE HYDROCHLORIDE CHEWABLE TABLET

Abstract

A novel gradient reverse phase liquid chromatographic (HPLC) method was developed for the determination of cetirizine mannitol ester impurity in cetirizine chewable tablet where mannitol was used as one of excipient and cetirizine mannitol ester impurity was formed during thermal stress tablet. The method was developed using ZodiacSIL 120-C-C18 AQ, 150 × 4.6 mm, 3 µm column with mobile phase containing a gradient mixture of solvent A and B. 0.01 M phosphate buffer (sodium dihydrogen phosphate monohydrate), pH 7.0 was used as buffer. Buffer pH 7.0 and methanol in 80:20 v/v ratios was used as solvent A and buffer pH 7.0 and methanol in 20:80 v/v ratio was used as solvent B. The gradient program (T/%B) was set as 0/70, 15/70, 20/85, 22/100, 25/100, 26/70, and 32/70 with a flow rate of 0.9 mL/minute. The eluted compounds cetirizine mannitol ester impurity and cetirizine hydrochloride peak were monitored at 230 nm. The run time was 32 min. Cetirizine chewable tablet was subjected to the stress conditions of oxidative, acid, base, hydrolytic, and thermal degradation. The peak purity of cetirizine mannitol ester impurity peak and cetirizine hydrochloride peak did not show any flag, thus proved the stability-indicating power of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness.

Keywords:

• cetirizine dihydrochloride chewable tablets
• Cetirizine mannitol ester impurity
• HPLC method
• LCMS method
• method development
• validation

ACKNOWLEDGMENTS

The authors wish to thank the management of Dr. Reddy's Laboratories Ltd. for supporting this work. Cooperation from colleagues and of Research & Development and Analytical Research & Development of Dr. Reddy's Laboratories Ltd. is appreciated.

Notes

^a Relative retention times (RRT) were calculated against the retention time (RT) of Cetirizine peak.

RSD (%) values calculated with three sample recovery at each level.