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Stress Degradation on Acotiamide and Development of a Validated Stability Indicating RP-HPLC Assay
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| Author:
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SANDHRA DAVIS, MANJUSHA MURALEEDHARAN, KRISHNANUNNI P S, ANEESH T P
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| Abstract:
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The stability-indicating reverse phase liquid chromatographic method (RP-HPLC) was developed and validated for the estimation of Acotiamide in its pharmaceutical dosage forms. The separation was performed by using Phenomenex C18 (250× 4.6mm, 5µm) column on a Shimadzu binary gradient liquid chromatography system, equipped with a photodiode array detector. The analysis was performed using an isocratic method with a mobile phase consisting of a mixture of pH-7.4potassium dihydrogen phosphate buffer and 40:60v/v acetonitrile as a mobile phase with a flow rate of 1ml/min. The retention time of acotiamide in the pharmaceutical formulation was to be 2.72 min with a run time of 7 min. The linearity range of the drug was found to be 10-100µg/ml, with a correlation coefficient (r2) 0.998. The approach was validated for specificity, accuracy, precision, linearity, robustness, and system suitability parameters according to ICH Guidelines. The drug stability was determined by degradation studies that were done under acidic, alkaline, oxidative, neutral, and thermal conditions. This developed methodology allows acotiamide to be determined precisely, sensitively, and reliably in a single chromatographic test, which is useful in dosage forms for drug estimation.
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| Keyword:
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Acotiamide; RP-HPLC; method development; validation; stability studies.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.SP1.285
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| Download:
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