High-performance liquid chromatographic determination of Tornalate in solution dosage forms; a specificity study

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Accurate quantification of active pharmaceutical ingredients is crucial for quality control.
• Development of robust analytical methods is essential for pharmaceutical product release.

Purpose of the Study:

• To develop and validate a reversed-phase high-performance liquid chromatography (RP-HPLC) method for Tornalate quantification.
• To establish a specific and linear assay for Tornalate in solution dosage forms.

Main Methods:

• Ion-pairing reversed-phase high-performance liquid chromatography (RP-HPLC).
• Specificity assessment through stressed sample analysis and peak purity tests (spectral overlay, rechromatography).
• Linearity evaluation via synthetic sample recovery and detector response analysis.

Main Results:

• The developed RP-HPLC method demonstrated high specificity for Tornalate.
• Peak homogeneity tests confirmed the absence of interfering impurities.
• The method exhibited excellent linearity, indicating reliable quantitative performance.

Conclusions:

• A validated ion-pairing RP-HPLC method is suitable for the accurate measurement of Tornalate in solution dosage forms.
• The method's specificity and linearity support its use in pharmaceutical quality control and regulatory submissions.