Stability Indicating Method for Simultaneous Estimation of Cinnarizine and Dimenhydrinate by HPLC
DOI:
https://doi.org/10.48047/yrje9k54Keywords:
Cinnarizine (CNZ), Dimenhydrinate (DMH), HPLC, Validation, Linearity, Recovery Study, Forced Degradation, Tablet Assay, System Suitability, Sensitivity, Pharmaceutical Formulation.Abstract
A novel and validated High-Performance Liquid Chromatography (HPLC) method has been developed for
the simultaneous quantification of Cinnarizine (CNZ) and Dimenhydrinate (DMH) in pharmaceutical
formulations. The method was optimized and validated in accordance with ICH guidelines. The linearity
of the method was confirmed in the concentration range of 2-10 µg/ml for both CNZ and DMH, with
correlation coefficients (r²) of 0.9998 and 0.999, respectively. The system suitability parameters, including
retention time, theoretical plates, and tailing factor, were within acceptable limits, ensuring the accuracy
of the method. Recovery studies at three concentration levels (80%, 100%, and 120%) demonstrated good
accuracy and precision, with mean recoveries ranging from 96.73% to 99.07% for CNZ and 96.73% to
99.07% for DMH.
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