A new simple and rapid validated RP-HPLC method for determination of ziprasidone in ziprasidone capsules

Abstract

In this work, a new isocratic reverse phase chromatographic method was developed using HPLC for ziprasidone hydrochloride monohydrate (ZHM). The newly developed method is applicable for assay determination of the ZHM in capsule dosage form. The chromatographic separation of ZHM was achieved on a Zorbax SB C-8 (50 × 4.6) mm, 3.5 μm column within a short runtime of 2 min. The method was validated according to the International Conference on Harmonization (ICH) guidelines with respect to specificity, precision, linearity, accuracy, range, stability of analytical solution, robustness and system suitability. The satisfying recoveries (98–100%) and low coefficient of variation confirmed the suitability of the proposed method for the routine analysis of ZHM in pharmaceuticals.

Keywords

• HPLC
• Isocratic
• Ziprasidone hydrochloride monohydrate
• Assay
• Validation
• Capsule