Development and Validation of a Reliable HPLC Method for Chlorpromazine Analysis

The present study aimed to develop and validate a simple, accurate, precise, robust, and cost-effective reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative estimation of chlorpromazine in bulk drug and tablet dosage forms in accordance with ICH guidelines. Chromatographic separation was achieved using a C18 column (250 × 4.6 mm, 5 µm) with an optimized mobile phase consisting of acetonitrile and water (40:60, v/v) adjusted to pH 3.5, at a flow rate of 1.0 mL/min and UV detection at 260 nm. The developed method exhibited excellent linearity over the concentration range of 10–60 µg/mL with a correlation coefficient (R²) of 0.9899. Validation studies demonstrated satisfactory accuracy (98.2–102.68% recovery), precision (%RSD < 2%), specificity, robustness, and system suitability. The method showed high sensitivity with low limits of detection (LOD) and quantification (LOQ), making it suitable for routine pharmaceutical quality control. Additionally, a Quality by Design (QbD)-based robustness assessment employing Central Composite Design (CCD) was performed to evaluate the influence of critical method parameters, including pH, mobile phase composition, and flow rate, on critical quality attributes. Statistical analysis using ANOVA confirmed the significance and reliability of the optimized chromatographic conditions. The developed RP-HPLC method is simple, reproducible, environmentally conscious due to reduced solvent consumption, and well suited for routine estimation of chlorpromazine in pharmaceutical formulations.