Validated RP-HPLC Method for Organic Impurities in Aripiprazole Tablets and Drug Substance

BACKGROUND: RP-HPLC gained recognition as an analytical technique due to its versatility in separating multiple components within a single chromatographic run. OBJECTIVE: The study aimed to establish a precise method for quantifying Aripiprazole in both the topical formulation and the active pharmaceutical ingredient. This involved creating a robust HPLC assay for analyzing the topical formulation. Aripiprazole is frequently prescribed for psychiatric disorders. METHODS: Aripiprazole was separated using an Inertsil ODS column (150 mm×4.6 mm, 5 μm) with a gradient elution method employing two mobile phases. Mobile Phase-A, likely pH-adjusted aqueous solution, started at 85%. Flow rate: 1.5 mL/min. Gradient: 10 min at 70%, 15 min at 65%, 18 min at 65%, 24 min at 50%, 34 min at 40%, returning to 85% at 35 min, concluding at 45 min. RESULTS: The method employed UV detection at 252 nm, matching Aripiprazole's likely absorbance peak, facilitating quantification. Calibration plots showed linearity from LOQ to 125% of the range. LOD was 0.03 µg/mL, ensuring reliable detection. LOQ at 0.15 µg/mL allowed precise quantification, suitable for pharmaceutical quality control. CONCLUSION: In summary, the HPLC method is tailored for aripiprazole tablet analysis, prioritizing the detection of organic impurities. It employs gradient elution with two mobile phases, UV detection, and offers a wide linear calibration range, low detection and quantification limits, high recovery, and minimal relative standard deviation (RSD). This renders it highly suitable for pharmaceutical quality control and testing.