Development of a near IR method for rapid determination of tiopronin for injection / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a near infrared spectroscopy method for the determination of the concentration of tiopronin for injection. METHODS: By using optical fiber probes and 1 mm sampling accessories, the near infrared transmission reflectance spectra of tiopronin for injection from seven pharmaceutical factories were obtained. The partial least square method was applied to establish the model with HPLC as the reference method. RESULTS: The model had a good prediction performance. The value of the correlation coefficient (r2) was 99.0%, the mean difference of prediction for test sets was 1.30%, and the root mean square error of prediction (RMSEP) was 0.982%. CONCLUSION: NIR is a rapid, reliable and powerful method for the quantitation of tiopronin for injection, and can be applied to rapid drug determination on the spot and stability study. Copyright 2012 by the Chinese Pharmaceutical Association.