Quantitative determination of haloperidol in tablets by high performance thin-layer chromatography

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis
• Chromatography

Background:

• Accurate quantification of active pharmaceutical ingredients is crucial for drug quality control.
• Haloperidol is an antipsychotic medication requiring precise dosage determination.
• Existing analytical methods may have limitations in speed, specificity, or cost-effectiveness.

Purpose of the Study:

• To develop and validate a densitometric high-performance thin-layer chromatography (HPTLC) method for haloperidol quantification in tablets.
• To establish a fast, specific, precise, and accurate analytical method for pharmaceutical quality control.

Main Methods:

• Developed a densitometric HPTLC method using precoated silica gel F254 plates.
• Employed a mobile phase mixture of acetone/chloroform/n-butanol/acetic acid glacial/water (5:10:10:2.5:2.5 v/v/v/v/v).
• Quantification was performed at a wavelength of 254 nm.

Main Results:

• The method demonstrated linearity in the 10-100 ng/µL range with R² = 0.999.
• Precision (CV) was ≤ 2.35%, and accuracy ranged from 97.76% to 100.33% (CV ≤ 4.50%).
• Achieved a detection limit of 0.89 ng/µL and a quantification limit of 2.71 ng/µL.

Conclusions:

• The developed HPTLC method is suitable for the accurate and precise quantitative determination of haloperidol in pharmaceutical tablets.
• The method is validated and successfully applied to real samples, showing good agreement with HPLC.
• This HPTLC technique offers a rapid and reliable alternative for pharmaceutical analysis of haloperidol.