Quantitative estimation and validation of Alectinib hydrochloride drug substance using quantitative nuclear magnetic resonance spectroscopy
1 Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, India.
2 Sun Pharmaceuticals Industries Ltd., Tandalja, Vadodara, Gujarat, India.
Research Article
GSC Biological and Pharmaceutical Sciences, 2024, 29(01), 155–165.
Article DOI: 10.30574/gscbps.2024.29.1.0340
Publication history:
Received on 15 August 2024; revised on 30 September 2024; accepted on 03 October 2024
Abstract:
Nuclear magnetic resonance spectroscopy has been recently used for quantitative estimation of drug substance which has numerous merits in pharmaceutical applications when compared to traditional methods of chromatography. Present study focuses on method development and validation of quantitative proton nuclear magnetic spectroscopy method for estimation of alectinib hydrochloride drug substance. This method involves use of internal standard in presence of alectinib hydrochloride. For quantitation, 1H NMR signals at 8.4 ppm and 6.7 ppm corresponding to analyte proton of alectinib and ethyl 4-(dimethyl amino) benzoate internal standard respectively were used. Moreover, this method was validated as per ICH guidelines for accuracy, precision, linearity, limit of detection, limit of quantitation, range and robustness. Assay estimation by Q-NMR is facile and time-efficient which does not require reference standard of analyte and yet accurate and precise alternative as compared to estimation by other chromatographic techniques.
Keywords:
Alectinib; quantitative NMR; Q-NMR; Alectinib NMR; Alectinib Quantification
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