Determination and quantification of cetirizine HCl in dosage formulations by RP-HPLC.

A simple, sensitive, reliable and rapid HPLC method for the determination of cetirizine hydrochloride using hyoscine butyl bromide as an internal standard has been developed. The chromatographic system consisted of Shimadzu LC-10 AT VP pump, SPD-10 AV VP with UV/visible detector and a CBM-102 Bus Module integrator. Separation was achieved on the U Bondapak 125 A C18 10 microm column at room temperature. The samples were introduced through an injector valve with a 10 microl sample loop. Acetonitrile-water (1:1 v/v) was used as mobile phase, with flow rate 2 ml/minute. pH was adjusted to 2.9 with phosphoric acid. UV detection was performed at 205 nm. The results obtained showed a good agreement with the declared content. Recovery values for cetirizine hydrochloride were 99.19-100.82%. The proposed method is reliable rapid, precise, selective and may be used for the quantitative analysis of cetirizine HCl, in presence of hyoscine butyl bromide as internal standard. The method was valid was for the determination in raw materials, bulk drug and formulations. The limit of quantification was 5-30 nano grams, while the limit of detection was 0.4 nano grams.