Approach To A Common Method For Construction Of NIR Universal Quantitative Models Of Pharmaceutical Solution

With support of the Chinese State Food and Drug Administration (SFDA) a large scale study of using Near Infrared Spectroscopy (NIR) as a quick screening tool for fake and counterfeit drugs was carried out by National Institute for the Control of Pharmaceutical and Biological Products of China, and the NIR screening system was equipped in a Mobile Vehicle and put gradually into use in recent years. The near infrared system for fake drug identification consisted of many universal qualitative and quantitative models which were constructed by collecting the same products from different manufacturers. However, up to now, there are no any NIR universal models of pharmaceutical solution in the NIR system.In this paper, Levofloxacin Hydrochloride Injection was used as examples to study how to establish a common method for constructing NIR universal quantitative models of pharmaceutical solution. In order to remove the influence on spectra, many affections were studied such as determination temperature, sampling accessories of NIR and manufacture process or formulation of drug. Then the rules on how to set up these universal quantitative models of solution were summarized:1. Recorded spectra at constant temperature.2. Made a cluster analysis for all spectra, then selected a subclass which containedmost of the samples to construct initial calibration model. To optimize the model, the residue samples were add in step by step.3. Some representative spectra, recorded at minimum and maximum temperature overwhole using temperature range were add in the initial model, too.4. The suitable spectral wavelength ranges were selected based on the factor spectra ofthe sample and water.5. Evaluated the model in terms of transferability, selectivity, linearity, precision,accuracy and robustness.When constructing universal quantitative models of Lomefloxacin Hydrochloride Injection and Fleroxacin Injection, these rules were assessed. The results showed that it can be as a guardline for setting up a universal quantitative model to quickly analyze a solution product from different manufacturers.At the end of this paper, some methods on how to construct a universal qualitative model for injection were also discussed by building qualitative model of Quinolone injection.