Yogendra Singh, Subhash Pande, Bhupendra Singh, Veerma Ram, Anil Bhandari
Yogendra Singh1*, Subhash Pande2, Bhupendra Singh1, Veerma Ram1 and Anil Bhandari1
1Faculty of Pharmaceutical Sciences, Jodhpur National University, Narnadi, Jhanwar Road, Jodphur – 342003, Rajasthan, India
2Sr. Vice President CQA, Glenmark Pharmaceuticals Ltd., Mumbai
Volume - 5,
Issue - 1,
Year - 2012
Cetirizine dihydrochloride (CZ) is (RS)-2-[2-[4-[(4- chlorophenyl) phenyl methyl] piperazine-1-yl] ethoxy] acetic acid dihydrochloride and is a long acting non-sedating antihistamine drug with some mast-cell stabilizing activity. CZ is therapeutically applied for the symptomatic relief of allergic conditions including rhinitis and chronic urticaria1. Basically CZ was assayed in bulk material by acid base titration2,3 and HPLC4,5. In various pharmaceutical formulations6,7–10 CZ was assayed by Various HPLC methods where C18 columns of different brands were used. The mobile phases mainly consisted acetonitrile and phosphate buffer of different pH values. The detection was carried out by UV detection at 230 nm or 254 nm. Other techniques such as ultraviolet spectrophotometry6,11,12, spectro?uorimetry13,14, calorimetry6,14-17 and ion- selective electrodes18 were also used for CZ assay in pharmaceutical formulations . Studies also reported TLC and HPTLC methods for the determination of CZ as a bulk material and in formulations, respectively19,20]. But there were very limited methods reported in literature for the determination of CZ related impurities3,21. Although The European Pharmacopoeia depicted a method3 for the determination of CZ related impurities, namely: A, B, C, D, E and F. The chromatographic system used in this method was equipped with a column of 250 × 4.6mm packed with 5 µm silica gel and the mobile phase was a mixture of dilute sulfuric acid: water: acetonitrile (0.4:6.6:93, v/v/v) with the ?ow rate set at 1ml/min and the detection made at 230 nm. A grown body of literature demonstrated several disadvantages of this particular method such as rapid column deterioration at lower ph of the mobile phase (<0.5).
Cite this article:
Yogendra Singh, Subhash Pande, Bhupendra Singh, Veerma Ram, Anil Bhandari. Determination of Cetrizine Dihydrochloride and a Related Impurity in Oral Solution and Tablet Dosage Forms Using HPLC. Asian J. Research Chem. 5(1): January 2012; Page 87-92.