<![CDATA[Cyproheptadine hydrochloride is an antihistamine drug widely available in tablet dosage forms; therefore, a validated analytical method is required to ensure product quality. This study aimed to develop and validate a Reversed-Phase High Performance Liquid Chromatography (RP-HPLC) method for the determination of cyproheptadine hydrochloride 4 mg in tablets according to ICH Q2(R2) and USP 2024 guidelines. The analysis was performed using an XBridge C18 column (2.1 mm × 50 mm; 3.5 µm) with an isocratic mobile phase of acetonitrile:0.1% acetic acid (60:40), a flow rate of 1.0 mL/min, an injection volume of 10 µL, and PDA detection at 285 nm. Validation parameters included specificity, linearity, accuracy, precision, robustness, LOD and LOQ. The method showed excellent linearity with R² of 0.997, recovery of 100.26%, precision with % RSD of 1.42%, LOD 0.0022% and LOQ of 0.0066%. Specificity testing showed no interfering peaks, while robustness was confirmed for a ±5% change in mobile phase composition (%RSD 1.26% for retention time and 1.97% for peak area) but not for a ±5% change in flow rate, where retention time gave %RSD of 2.14%. The procedure is fit for routine quality control assay of cyproheptadine hydrochloride tablets, with the stated limitation on flow-rate robustness.]]>
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