Authors : Sandip Jana; Dr. Syed Mujtaba Ahmed; Dr. Mohd. Mudassir Hussain

Volume/Issue : Volume 11 - 2026, Issue 7 - July

Google Scholar : https://tinyurl.com/4w5jvkhd

DOI : https://doi.org/10.38124/ijisrt/26jul1093

Note : A published paper may take 4-5 working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and ResearchGate.

Abstract : The chromatographic method validation for the test procedure of related substances for Ziprasidone Hydrochloride was simple, reliable, sensitive and less time consuming. Weigh accurately about 60mg of Ziprasidone hydrochloride working standard in a 100ml volumetric flask. Dissolve and dilute to the volume with the diluents and mix. Pipette out 5.0ml of the solution in a 100ml volumetric flask and dilute to the volume with the diluent. Further dilute 5ml of this solution to 50ml with diluent, and mix (3ppm).  Test Preparation: Weigh accurately about 75mg of sample in a 50ml volumetric flask. Sonicate to dissolve and dilute to volume with the diluent and mix (1500ppm).  System Suitability Preparation: Weigh accurately about 37.5mg of Ziprasidone hydrochloride working standard and 2.5mg of impurity-C working standard in a 25ml volumetric flask. Dissolve and dilute to volume with the diluent and mix (1500ppm of Ziprasidone hydrochloride and 100ppm of impurity-C).  Procedure: Inject diluent as a blank followed by single injection of system suitability preparation into above chromatographic system. Record the chromatograms and measure the system suitability parameters. Limits are as below; the resolution between peaks due to Ziprasidone and impurity –C should not be less than 2. If system suitability passes, then make three replicate injections of standard preparation and record the chromatograms. Relative standard deviation for the area of three replicate injections of standard preparation should not be more than 5%. If relative standard deviation passes, then make single injection of test preparation and record the chromatograms.

Keywords : Validation, Chromatogram, Ziprasidone, Mobile Phase, Replicate Injections.

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