Development and validation of RP- HPLC method for the determination of Ziprasidone in bulk and pharmaceutical dosage form
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2016, Vol 4, Issue 1
Abstract
A simple, accurate, highly sensitive, efficient, precise and reproducible isocratic reverse phase - high performance liquid chromatographic method was developed and validated for the quantitative analysis of Ziprasidone in pharmaceutical forms. The separation was achieved on Shimadzu LC-20AT Prominence Liquid Chromatograph having a Welchrom C18 isocratic column (250 × 4.6 mm i.d., particle size 5 μm, maintained at ambient temperature) used as stationary phase. Acetonitrile: Water (50:50 v/v), adjusted to pH 3.3 with ortho phosphoric acid, and added drop wise, as mobile phase. The flow rate was set to 1.0 mL/minutes. The wavelength was determined at 251 nm using Shimadzu SPD-20A prominence UV-Vis detector. A well-defined chromatographic peak of Ziprasidone was exhibited with a retention time of 6.707 minutes and tailing factor of 1.11. Linearity was recognized for Ziprasidone in the range of 2-10 μg/mL with correlation coefficient 0.9999.Validation parameters such as specificity, linearity, precision, accuracy, and robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated. The projected methods were validated according to International Conference on Harmonization ICH Q2 (R1) guidelines. The developed method was successfully applied for the quantitative analysis of commercially available dosage form.
Authors and Affiliations
P. Ravisankar, K. Anusha Rani, H. Anusha, V. Himaja, S. Bhavitha, S. Gowthami
Keywords
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- EP ID EP33365
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