Quantitative determination and validation of Carvedilol in pharmaceuticals using quantitative nuclear magnetic resonance spectroscopy

Abstract

A rapid, specific and accurate proton nuclear magnetic resonance spectroscopy (1H-NMR) method was developed to determine Carvedilol antihypertensive drug in pharmaceutical tablet formulation. The method was based on quantitative NMR spectroscopy (qNMR) using Maleic acid as an internal standard and deuterated dimethyl sulfoxide (DMSO-d6) as an NMR solvent. For the quantification of the drug, the 1H-NMR signals at 8.20 ppm and 6.00 ppm corresponding to the analyte proton of Carvedilol and Maleic acid internal reference standard (IS) respectively were used. The method was validated for the parameters of specificity, precision, intermediate precision, linearity, range, limit of detection (LOD), limit of quantification (LOQ), accuracy, solution stability and robustness. The linearity of the calibration curve for analyte in the desired concentration range was good (R2 > 0.9980). The method was accurate and precise with good recoveries. The range study was also performed up to saturation level (338.24 mg/0.60 mL) in DMSO-d6. 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 Carvedilol in commercial formulation products.