Application of NIR chemometric methods for quantification of the crystalline fraction of warfarin sodium in drug product

• DOI: 10.3109/03639045.2015.1058817
• Publication Date: 2015-07-10T16:28:34Z
• Authors: Maxwell Korang-Ye...; Sohail Akhtar; Akhtar Siddiqui; Ziyaur Rahman; Mansoor A. Khan
• Keywords: Excipient; Anhydrous; Principal component regression; Chemometrics; Pharmaceutical formulation

Monitoring of the physical state warfarin sodium (WS) in products is essential for minimizing product quality variability order to ensure consistent clinical performance. This study reports development chemometric models quantifying crystalline and amorphous fractions WS commercial drug using NIR spectroscopy. Formulations based on commercially available with different API excipient ratio were used study. For each content, two formulations containing either lactose monohydrate or anhydrous as predominant formulation prepared. Two 100% (AWS) (CWS) prepared mixed various ratios obtain sample matrices AWS/CWS 0–100%. The uniformity samples was confirmed by near infrared chemical imaging. Data mathematically pretreated multiplicative signal correction Savitzky–Golay second derivative. Principal component regression partial least square developed from treated data. All showed linear trend indicated correlation R2 > 0.99 >0.98, respectively. demonstrated good performance parameters a low-root mean squared error, standard error bias. model predicted CWS AWS contents very close agreement actual values. utility methods quantification and/or fraction its products.