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A stability-indicating LC method for citalopram hydrobromide

K.Rama Seshaiah, Sudip Kr.Samanta, V.Krishna Reddy, VVNKV Prasadaraju, K.Mukkanti, V.Ranga Reddy

A simple, inexpensive and rapid LC method has been developed for the quantative determination ofCitalopram, an anti-depressant drug. Themethod can also be employed for the determination of Citalopramand its impurities in the bulk drug. Degradation studies were performed on the bulk drug by heating to 105 °C, exposure to UV light at an energy of 200 Watt hours/ m2and toVisible light at an illumination of not less than 1.2million lux hours, acid (0.5 N hydrochloric acid), base (0.1 N sodium hydroxide) aqueous hydrolysis and oxidation with 3.0% v/v hydrogen peroxide and 0.2% w/w Meta chloro per benzoic acid. Considerable degradation was observed under acid, base and oxidation conditions. Good resolution between the peaks corresponding to impurities produced during synthesis, degradation products and the analyte was achieved on a Symmetry C18 LC column using a mobile phase consisting of a mixture of aqueous potassium dihydrogen phosphate, N,N-Dimethyl octyl amine, methanol and acetonitrile. The degradation samples were assayed against the reference standard of Citalopram and the mass balance in each case was close to 99.9%. Validation of the method was carried out as per ICH requirements.