Whiteness and greenness appraisal approaches for quantitative determination of recently approved combination of indacaterol and mometasone via utilization of nuclear magnetic resonance technique

Abstract

Quantitative proton nuclear magnetic resonance (1H-qNMR) is currently being used in a variety of applications in many disciplines due to the great privileges. Economical and minimal solvent system volume is utilized; no sample labelling or pre-treatment is necessary. Furthermore, no sample destruction is occurred. The all aforementioned benefits are contributed to its suitability for employment in pharmaceutical companies and quality control laboratories. Starting from this significance, a simple, quick, and sustainable method was developed for the determination of indacaterol (IND) and mometasone (MOM) in the raw material and newly approved pharmaceutical dosage form Atectura Breezhaler®. The developed approach involved the utility of pyridoxine (PYR) as an internal standard (IS) and DMSO-d6 as the suitable deuterated solvent for the analysis. The quantitative peaks of IND (doublet at 8.247 and 8.254 ppm) and MOM (singlet at 1.014 ppm) were obviously disengaged from the IS peak; which was singlet peak at 8.082 ppm. The developed methodology was perfectly linear over concentration range of 0.05–5.00 and 0.001–1.00 mg/mL for IND and MOM, respectively. The developed protocol was applied successfully for the determination of IND and MOM mixtures, including capsule-based inhaler dosage form with % recovery of 100.15% and 97.98% for IND and MOM, respectively. Also, the greenness and whiteness (GAPI, AGREE and RGB-algorithm approaches) of the evolved method were evaluated in order to assess its impacts on the ecosystem. The method was proved to possess ecofriendly properties without any expected harmful effects on the environment.