RP- HPLC METHOD DEVELOPMENT AND VALIDATION OF CANDESARTAN CILEXETIL IN BULK AND THEIR PHARMACEUTICAL DOSAGE FORMSAbstract
This paper describes the analytical method suitable for validation of Candesartan Cilexetil (CDN) by reversed Phase liquid chromatography (RP-LC) method. The method utilized RP-LC (Shimadzu LC-10AT with UV detector) model and Hypersil ODS C-18 (250 x 4.6 mm, packed with 5 micron) column was used for the separation. The mobile phase was consists of acetonitrile:0.05 M KH2PO4 buffer in the ratio of 65:35 at flow rate of 1.5 ml/ min. Validation experiments were performed to demonstrate System suitability, Specificity, Precision, Linearity, Accuracy study. The method was linear over the concentration range of 0.5-400 mg/ml. The method showed good recoveries (99.54- 100.41%) and the recovery studies were carried out by adding different amounts (80%, 100% & 120%) of bulk samples of Candesartan cilexetil along with internal standard were 100.04%, 99.98% & 99.64% respectively. The proposed method is Precise, Accurate, Reproducible and rapid for the determination of Candesartan cilexetil in bulk and their pharmaceutical dosage forms.
Ganesh Akula*, Kandikonda Saikrishna , Saikumar Bhupathi , Rasapally Ramesh Kumar and Santhosh Kumar K
Procadence Institute of Pharmaceutical Sciences, Gajwel, Medak, AndhraPradesh, India
25 July, 2010
22 October, 2010
16 November, 2010
01 December, 2010