[Quantitative Analysis for Levocetirizine Hydrochloride Tablets Based on NIR Spectroscopy].

Area of Science:

• Analytical Chemistry
• Spectroscopy
• Chemometrics

Context:

• Accurate quantification of active pharmaceutical ingredients (APIs) is crucial for drug quality control.
• Traditional analytical methods for pharmaceuticals can be time-consuming and resource-intensive.
• Near-infrared (NIR) spectroscopy offers a rapid, non-destructive analytical technique.

Purpose:

• To develop and validate a quantitative analytical method for determining the effective components in cetirizine hydrochloride tablets.
• To utilize near-infrared spectroscopy (NIR) combined with partial least squares (PLS) analysis for this purpose.
• To establish a reliable model for rapid quality assessment of cetirizine hydrochloride formulations.

Summary:

• A quantitative method was developed using near-infrared spectroscopy (NIR) and partial least squares (PLS) analysis for cetirizine hydrochloride tablets.
• The method involved internal cross-validation to optimize spectral preprocessing, wavelength selection, and principal component analysis.
• The resulting PLS model demonstrated high predictability, with a Root Mean Square Error of Cross-Validation (RMSECV) of 0.276 and R-squared (R²) of 0.974.

Impact:

• The developed NIR-PLS model provides a rapid and accurate approach for the quantitative analysis of cetirizine hydrochloride.
• This method can be applied for quality control of cetirizine hydrochloride tablets from different manufacturers.
• Facilitates faster batch release and ensures consistent drug quality in pharmaceutical manufacturing.