Development and validation of stability indicating assay method of cetirizine hydrochloride by HPLC

A new simple and rapid high performance liquid chromatography (HPLC) method was developed for the determination of cetirizine hydrochloride (CTZ) in tablets using CLC-ODS reverse phase column (4.6 × 250 mm, 5 µm). Salicylic acid was used as internal standard. A mixture of methanol and water of 70:30 with pH 4 (adjusted with o-phosphoric acid) was used as mobile phase. The eluents were detected at 231 nm. The coefficient of determination of calibration curve for CTZ and salicylic acid in mobile phase were 0.9898 and 0.9925, respectively. The limit of detection for CTZ was 4 µg ml-1. The proposed method was successfully applied for the stability study of CTZ. The CTZ was found to be stable at accelerated condition of temperature and relative humidity after storage of six months. This method can be used for the routine quality control and dosage form assay of CTZ in pharmaceutical preparations.   Key words: High performance liquid chromatography, cetirizine hydrochloride, pharmaceutical preparations.