DEVELOPMENT OF VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF IRBESARTAN IN BULK AND PHARMACEUTICAL DOSAGE FORMSAbstract
A stability indicating RP-HPLC method was developed and validated for the determination of Irbesartan in bulk and dosage forms using Telmisartan (10 μg/ml) as the internal standard. An Inert ODS C-18, 5μm column having 250 x 4.6mm internal diameter in isocratic mode with mobile phase containing methanol: water (90:10) and the pH was adjusted to 3 with 1 % GAA. The flow rate was 1 ml/min and effluents were monitored at the wavelength of 246 nm. The retention time for Irbesartan was 2.3 min. The method was validated as per ICH guidelines for linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. Limit of detection (LOD) and limit of quantification (LOQ) were found 6.51μg/ml and 1.973μg/ml respectively and recovery of Irbesartan from bulk and dosage forms was found from 99.94% to 99.97%. As the separation of the degradants using this mobile phase is quite good, isolation of the degradants with preparative techniques can also be achieved using this mobile phase. The drug was prone to degrade more in acidic, alkaline, oxidative and thermal conditions. Further LC MS-MS analysis will help to deduce the structures of the degradants which can help to establish the possible degradation pathway of this drug. So this method can be economically very useful in both research and industrial aspect.
Kishanta Kumar Pradhan
Department of Pharmaceutical Sciences and Technology, Birla Institute of Technology, MESRA, Ranchi, Jharkhand, India
02 June, 2016
19 September, 2016
03 October, 2016
01 November, 2016