Abstract

“QUANTITATIVE DETERMINATION AND VALIDATION OF CLARITHROMYCIN IN PHARMACEUTICAL USING QUANTITATIVE NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY”

Deepti Aggarwal*, Ram Dayal Gupta, Shabnam Ain and Vijay Sharma

Abstract

A rapid, specific and accurate proton nuclear magnetic resonance spectroscopy (1H-NMR) method was developed to determine Clarithromycin macrolide antibiotic drug drug in pharmaceutical tablet formulation. The method was based on quantitative NMR spectroscopy (QNMR) using Tetra methyl benzene (TMB) as an internal standard and deuterated dimethylsulfoxide (DMSO-d6) as NMR solvent. For the quantification of the drug, the 1H-NMR signals at 6.87 ppm corresponding to the analyte proton of Clarithromycin drug and internal reference standard (IS) Tetra methyl benzene (TMB) respectively were used. The method was validated for different validation 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 was good (R2 =0.9992). The method was accurate and precise. The merit of this method is that no reference standard of analyte drug is required for quantification. The method is non-destructive and can be applied for quantification of Clarithromycin in commercial formulation products. 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: Clarithromycin, NMR, New Method Development, Validation, QNMR.