Abstract

QUANTITATIVE DETERMINATION AND VALIDATION OF OLMESARTAN MEDOXOMIL IN PHARMACEUTICAL USING QUANTITATIVE NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY

Jeetendra Kumar*, Rajnish Kumar and Partha Mukharjee

Abstract

Rapid, specific and accurate Proton nuclear magnetic resonance spectroscopy (1H-NMR) method was developed to determine Olmesartan medoxomil drug in pharmaceutical tablet formulation. The method was based on quantitative NMR spectroscopy (qNMR) using Maleic acid as an internal standard and deuterated dimethylsulfoxide (DMSO- D6) as an NMR solvent. For the quantification of the drug, the 1H-NMR signals at 2.75 ppm and 6.25 ppm corresponding to the analyte proton of Olmesartan medoxomil drug and Maleic acid internal reference standard (IS) respectively were used. The method was validated for the parameters of specificity and selectivity, precision and intermediate precision, linearity, accuracy and robustness. The linearity of the calibration curve for analyte in the desired concentration range is good (R2 =0.9992). The method was accurate and precise. The advantage of the method is that no reference standard of analyte drug is required for quantification. The method is nondestructive and can be applied for quantification of Olmesartan medoxomil in commercial formulation products. The method was validated specificity, precision, linearity, accuracy and robustness. The linearity of Olmesartan- medoxomil was in the range and correlation coefficient was found to be 0.9962. The recovery was found in the range. The developed method was validated as per International Conference on Harmonization guidelines (ICH) with respect to specificity, linearity, accuracy, precision, solution stability and robustness.

Keywords: Olmesartan Medoxomil, NMR, new method development, validation, QNMR.