Construction of a universal quantitative model for ibuprofen sustained-release capsules from different manufacturers using near-infrared diffuse reflection spectroscopy

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.…”

“…using paired student ttests for evaluating the average accuracy of the method (also more correctly called trueness criteria). This approach has been used to assess this mean accuracy criteria in eleven of the publications validating NIRS method following ICH Q2 guidance leading each time to abusive conclusions about the acceptability of the absence of bias between the two analytical methods [17,45,[47][48][49][50][51][52][53][54]59]. The difference approach to assess the validity of analytical method has also been used in five cases study to assess the linearity criteria in order to demonstrate that the slope is equal to 1 and the intercept equal to 0 [17,45,50,53,54].…”

“…1, the 95% prediction intervals (For interpretation of the references to color in this text, the reader is referred to the web version of the article.) (blue dashed vertical segments) computed from 6 publications [17,47,49,53,59,61] have been obtained but only for a single concentration levels. In addition in Figs.…”

“…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 in Drug Discovery and Development Processes

“…Potential samples for analysis can be of various forms like powders, granulates, tablets, liquids, gels, films or lyophilised vials [107][108][109][110][111][112][113].…”