Abstract
This work developed a new method for determination of dipyrone (DIP) in oral pharmaceutical formulations, through the use of near infrared (NIR) transflectance measurements and multivariate calibration. The studied range varied from 300.0 to 569.2 mg mL-1. The best PLS (partial least squares) model was obtained with two latent variables and the root mean square errors of calibration and prediction were 1.1 and 1.0 mg mL-1, respectively. The proposed method was validated in accordance with ANVISA, the Brazilian regulatory agency, and ICH, being considered selective, linear, precise, accurate and robust. By comparison with the main alternatives, iodimetric titration and HPLC, this method is simpler, non-destructive, does not use reagents or solvents and does not produce chemical waste. Besides, its rapidity is considered the major advantage over the other methods, since only about 50 s were spent per assay.
Highlights
Dipyrone (DIP), the sodium salt of [(2,3-dihydro-1,5dimethyl-3-oxo-2-phenyl-1H-pyrazol-4yl)methylamino] methanesulfonic acid and known as methamizole, is a non steroidal anti-inflammatory drug (NSAID) used as analgesic, antipyretic and antispasmodic
The objective of this work was the development of a simple method for direct determination of DIP in oral pharmaceutical solutions, based on transflectance measurements on near infrared (NIR) region and multivariate calibration with partial least squares (PLS).[28]
Spectra of ten samples of DIP pharmaceutical preparations produced by IQUEGO were recorded for developing a spectral library used for Development and Validation of a Multivariate Calibration Model
Summary
Dipyrone (DIP), the sodium salt of [(2,3-dihydro-1,5dimethyl-3-oxo-2-phenyl-1H-pyrazol-4yl)methylamino] methanesulfonic acid and known as methamizole, is a non steroidal anti-inflammatory drug (NSAID) used as analgesic, antipyretic and antispasmodic. In Brazil, in spite of restrictions on the sales for some formulations based on DIP,[2] it has continued to be one of the most consumed analgesics. Brazilian[3] and European[4] Pharmacopoeias prescribe iodimetric titration for DIP determination, which is the most frequently method used in Brazilian pharmaceutical industry for the DIP quality control. This method has the drawbacks of low precision, long time of analysis and needing of cooling in iced water aiming to avoid loss of iodine by volatizalion. DIP has been determined in pharmaceutical formulations by HPLC,[4,5] UV-Visible spectrophotometry,[6,7,8,9,10] turbidimetry,[11] chemilumimetry,[12,13] amperometry[14] and voltammetry.[15,16] The most of these methods involve cumbersome steps, such as derivatization reactions, previous separations, solvent extraction, or sample filtration
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