University of Medicine and Pharmacy Iuliu Hatieganu Cluj-Napoca, Department of Pharmaceutical Technology and Biopharmaceutics, 41 Victor Babes Street, 400023, Cluj-Napoca, Romania.
J Pharm Biomed Anal. 2013 Oct;84:285-92. doi: 10.1016/j.jpba.2012.12.020. Epub 2012 Dec 22.
This paper describes the development, validation and application of NIR-chemometric methods for API content and pharmaceutical characterization (disintegration time and crushing strength) of indapamide intact tablets. Development of the method for chemical characterization was performed on samples corresponding to 80, 90, 100, 110 and 120% of indapamide content and for pharmaceutical characterization on samples prepared at nine different compression forces (covering the interval 7-45 kN). NIR spectra of prepared tablets were recorded in transmission mode, and partial least-squares followed by leave-one-out cross-validation were used to develop models for the prediction of the drug content and the pharmaceutical properties of tablets. All developed models were validated in terms of trueness, precision and accuracy. No statistical differences were found between results predicted by NIR-chemometric methods and the ones determined by reference methods. Therefore, the developed NIR-chemometric methods meet the requirements of a high-throughput method for the determination of drug content, pharmaceutical properties of indapamide tablets.
本文描述了近红外化学计量学方法的开发、验证和应用，用于测定吲达帕胺完整片剂的 API 含量和药物特性（崩解时间和破碎强度）。化学特征方法的开发是针对相当于吲达帕胺含量 80%、90%、100%、110%和 120%的样品进行的，而药物特性的方法开发则是针对在九个不同压缩力下（涵盖 7-45 kN 区间）制备的样品进行的。制备好的片剂的近红外光谱以透射模式记录，然后使用偏最小二乘法（PLS）结合留一法交叉验证来开发用于预测药物含量和片剂药物特性的模型。所有开发的模型均在准确性、精密度和准确度方面进行了验证。通过近红外化学计量学方法预测的结果与参考方法确定的结果之间没有发现统计学差异。因此，开发的近红外化学计量学方法满足了用于测定吲达帕胺片剂药物含量和药物特性的高通量方法的要求。
