Method Development and Validation of Aspirin and Ticlopidine Hydrochloride in Bulk Drug and Tablet Formulation by RP-HPLC
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Author:
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SAMPAT SHINDE, KACHAVE R.N, CHAUDHARI S.R
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Abstract:
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A simple, accurate and reproducible RP-HPLC has been developed for simultaneous determination of Aspirin and Ticlopidine Hydrochloride in Bulk and Tablet dosage form. The chromatography was carried out on the Inertsil ODS C18, 150mm x 4.6mm, 5µ column using a mobile phase composition of 0.02M. Potassium dihydrogen o-phosphate (pH 3.7) and Methanol at a flow are 3.3min and 7.3min respectively. The calibration curves were linear over the range 16µg/ rate of 1.0 ml/min that provides an optimal resolution of components in an acceptable elution time. The detection was made at 254 nm. The retention times of Aspirin and Ticlopidine Hydrochloride mL to 24µg/mL for Aspirin and 40µg/mL-60µg/mL for Ticlopidine HCl. The interday and intraday precision was found to be within limits. The proposed method has adequate sensitivity, reproducibility and specificity for the Simultaneous determination of Aspirin and Ticlopidine Hydrochloride in bulk and its tablet dosage forms. Accuracy (recoveries: 99.44 and 99.60%) and reproducibility were found to satisfactory. The proposed method was validated as per ICH and USP guidelines and it was found suitable for the routine quality control analysis of the drugs in tablet dosage forms.
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Keyword:
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Aspirin, Ticlopidine Hydrochloride, RP-HPLC, Method development and validation
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EOI:
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DOI:
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