A platform for designing quantitative infrared spectrophotometric method for drugs and pharmaceuticals analysis: a rediscover for an ecological and safer technique in the routine quality control laboratories

This paper describes the importance of an innovative analytical technique for drugs and pharmaceuticals quantification, using Fouriertransform infrared (FTIR) transmission spectroscopy. This method does not use organic solvents, which is one great advantage over the most common analytical methods. This fact contributes to minimize the generation of organic solvent waste by the industry and thereby reduces the impact of its activities on the environment. The method involved absorbance measurements of the band corresponding to one of the chosen group in the molecule. Obviously, the method should be validated according to ICH guidelines, showing linearity, precision, accuracy and robustness, over a concentration range, using small amounts to prepare the analyte. The validated method is able to quantify drugs and pharmaceuticals and can be used as an environmentally friendly alternative for the routine analysis in pharmaceutical industry quality control.

Validation of a stability indicating capillary electrophoresis method for the determination of darunavir in tablets and comparison with the of infrared absorption spectroscopic method

Darunavir (DRV) is a protease inhibitor used in the treatment of HIV infection, which constitutes a keystone in the therapy of patients infected with this virus. There is no monograph described in official compendia. The literature provides few methods of analysis for the determination of DRV in pharmaceuticals which include TLC, IR, UPLC, HPLC, HPLC-MS, HPLC-MS/MS, but there are no reports of the use of capillary electrophoresis (CE) for the determination of this drug. Thus, this research proposed the development and validation of a CE method for the determination of DRV in tablets. The method was completely validated according to the International Conference on Harmonization guidelines, showing linearity, selectivity, precision, accuracy and robustness. The migration was achieved in less than 1 minute using fused-silica uncoated capillary with an id of 50 μm and total length of 21 cm and voltage of +20 kV. The sample injection was performed in the hydrodynamic mode. The method was linear over the concentration range of 50-200 μg mL-1 with correlation coefficient 0.9998 and limits of detection and quantification of 7.29 and 22.09 μg mL-1, respectively. The drug was subjected to acid, base, oxidation and photolysis degradation. Degradation products were found interfering with the assay of DRV, therefore the method can be regarded as stability indicating. The validated method is useful and appropriate for the routine quality control of DRV in tablets.

Development and validation of the quantitative analysis of cefuroxime sodium in powder for injection by infrared spectroscopy

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Development and validation of the quantitative analysis of ceftazidime in powder for injection by infrared spectroscopy

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Development and validation of infrared spectroscopy method for the determination of darunavir in tabets

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)