Multivariate analysis of nystatin and metronidazole in a semi-solid matrix by means of diffuse reflectance NIR spectroscopy and PLS regression

Critical review of near-infrared spectroscopic methods validations in pharmaceutical applications

“…In particular, those who used only the traditional chemometric measure are de facto following this approach as the observed statistical parameters are compared to acceptable values . In addition, a none negligible number of the NIRS method that have been validated following ICH Q2 recommendations fall also into this category for at least the evaluation of one validation criteria (most often the precision and linearity validation criteria) [17,18,45,[47][48][49][50][51][52][53][54]59,61,62]. In particular, concerning the linearity criterion which is the relationship between the predicted results obtained from the NIRS and the reference results obtained by the reference method [14], it is evaluated by looking at the value of the correlation coefficient or the determination coefficient.…”

“…NIRS method validated following the ICH Q2 guideline can be found for the determination of water in pharmaceutical processes or drug products [45,46], API in various drug products [17,18,[45][46][47][48][49][50][51][52][53][54][55][56][57][58] or in various production steps [59,60], for the quantification adjuvant in vaccines [61], for the quantification of excipients [18,51] of antifungal and antibacterial agents [62]. From these applications it can be seen that the validation requirement imposed by ICH Q2 document is applicable to NIRS methods.…”

Near-infrared spectroscopy-based methods for quantitative determination of active pharmaceutical ingredient in transdermal gel formulations

“…In spite of the low concentration of measured ingredients (<4%) and the strong O-H bands of NIR spectra, they established partial least squares regression (PLSR) calibrations with acceptable relative errors. By contrast, Baratieri et al [14] used diffuse reflectance FT-NIR spectroscopy to analyze nystatin and metronidazole in pharmaceutical cream products. The validation tests of PLSR models for both active pharmaceutical ingredients (APIs) showed results within 95-105% of uncertainty.…”

Desenvolvimento e validação de método analítico para nistatina creme vaginal por cromatografia líquida de alta eficiência

“…Apresenta ação farmacológica contra Candida spp. e é amplamente utilizada no tratamento de infecções vaginais (Baratieri et al, 2006). Entre outras formas farmacêu-ticas, é comercializada como creme vaginal, produzido por diversos laboratórios farmacêuticos, incluindo o Laboratório Farmacêutico do Estado de Pernambuco -LAFEPE.…”