Analysis of haloperidol tablets by high-performance liquid chromatography--an inter-laboratory study

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Accurate determination of active pharmaceutical ingredients (APIs) like haloperidol in tablet formulations is crucial for patient safety and therapeutic efficacy.
• Established analytical methods require rigorous validation to ensure reliability in quality control settings.

Purpose of the Study:

• To develop and validate a high-performance liquid-chromatographic (HPLC) method for the quantitative determination of haloperidol in tablet dosage forms.
• To compare the accuracy and precision of the developed HPLC method against the British Pharmacopoeia 1973 spectrophotometric method.

Main Methods:

• Development and inter-laboratory evaluation of a high-performance liquid-chromatographic (HPLC) method.
• Concurrent evaluation of the British Pharmacopoeia 1973 spectrophotometric method for haloperidol determination.
• Comparative analysis of accuracy and precision using total error standard deviations.

Main Results:

• Thirteen laboratories successfully analyzed two commercial haloperidol tablet formulations using the HPLC method, reporting satisfactory column performance and assay precision.
• The total error standard deviation for the HPLC method was 3.92%, compared to 2.58% for the spectrophotometric method.
• Both methods yielded satisfactory results, but the HPLC method demonstrated robust performance across multiple laboratories.

Conclusions:

• The developed high-performance liquid-chromatographic (HPLC) method is suitable for the official testing and quality control of haloperidol in tablet formulations.
• The HPLC method provides a reliable and precise alternative for pharmaceutical analysis, meeting stringent regulatory requirements.
• Inter-laboratory studies confirm the robustness and applicability of the HPLC method in diverse analytical settings.