STABILITY INDICATING HPLC METHOD FOR THE DETERMINATION OF CANDESARTAN IN PHARMACEUTICAL DOSAGES FORMAbstract
Candesartan was degraded together under different stress test conditions prescribed by International Conference on Harmonization. The samples so generated were used to develop a stability-indicating high performance liquid chromatographic (HPLC) method for the candesartan. The drug was well separated from degradation products using a reversed-phase (C-18) column and a mobile phase comprising of Acetonitrile: Buffer (80:20 v/v) at pH- 3. Other HPLC parameters were: flow rate, 1 mL/min; detection wavelength, 225 nm; and injection volume 20 µl. The method was validated for linearity, precision, accuracy etc. Results obtained after validation study, indicating that the proposed single method allowed analysis of Candesartan, in the presence of their degradation products formed under a variety of stress conditions. The developed procedure was also applicable to the determination of stability of the drug in commercial pharmaceutical dosage form.
Sachin Bhagwate*, N. J. Gaikwad and Pawan Tarte
Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University Nagpur 440 033, Maharashtra, India
22 November, 2012
11 January, 2013
23 February, 2013
01 March, 2013