• ROHIT KUMBHKAR
• Dr. Sachin Kumar

Objective: To develop and validate a novel High-Performance Liquid Chromatography (HPLC) method for the determination and stability analysis of Ziprasidone, an antipsychotic medication used in treating schizophrenia and bipolar disorder. Methods: An HPLC system with a C18 column was utilized, employing a mobile phase of acetonitrile and phosphate buffer (pH 3.0) in a 60:40 v/v ratio. The flow rate was 1.0 mL/min, and detection was at 315 nm. Method validation followed ICH guidelines, assessing linearity, accuracy, precision, specificity, limit of detection (LOD), and limit of quantification (LOQ). Stability studies subjected Ziprasidone to hydrolysis, oxidation, photolysis, and thermal degradation. Results: The HPLC method exhibited excellent linearity over 1-100 μg/mL, with a correlation coefficient (R²) of 0.999. High precision was observed, with intra-day and inter-day relative standard deviations (RSD) below 2%. Accuracy showed recovery rates between 98.5% and 101.2%. The LOD and LOQ were 0.1 μg/mL and 0.3 μg/mL, respectively. Specificity tests indicated no significant interference from excipients and degradation products. Stability studies revealed that Ziprasidone is susceptible to acidic, basic, and oxidative conditions but stable under photolytic and thermal conditions. Conclusion: The developed HPLC method is simple, precise, accurate, and robust for Ziprasidone determination and stability analysis. It is suitable for routine quality control and stability testing of Ziprasidone in pharmaceutical formulations. The stability data ensure the drug's efficacy and safety throughout its shelf life.

Ziprasidone, HPLC, Stability study, Method validation, Pharmaceutical analysis

"DEVELOPMENT AND METHOD VALIDATION USING HPLC FOR ASSAY OF ZIPRASIDONE CAPSULE", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 6, page no.a428-a431, June-2024, Available :http://www.jetir.org/papers/JETIR2406053.pdf

"DEVELOPMENT AND METHOD VALIDATION USING HPLC FOR ASSAY OF ZIPRASIDONE CAPSULE", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 6, page no. ppa428-a431, June-2024, Available at : http://www.jetir.org/papers/JETIR2406053.pdf