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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Development and Validation of RP-HPLC Method for Estimation of Ondansetron HCL in Bulk and Pharmaceutical Dosage Form

Author: , DR SHAIKH SIRAJN, MAGAN G VASAVE, DR G J KHAN, PATEL M SIDDIK N, ANSARI YASIR A RAZZAQ, SIDDIQI HIFZURRAHMAN MD, A, MOLVI KHURSHID I, JAYESH C CHAUDHARY
Abstract: A Precise and feasible rapid reverse phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous estimation of antiemetic drug Ondansetron HCL in bulk drugs and pharmaceutical dosage form. The separation was accomplished Agilent technology HPLC AGILET (1100) With Auto Sampler on C-18 (id 4.6 x 150 mm, 2.5 µm) column with a mobile phase consisting of Methanol: 0.1 % Ortho-phosphoric acid Water (50:550 v/v) at a flow rate of 0.7 mL/min. The eluents were monitored at 248 nm. The retention time for Ondansetron HCL was 2.486min, respectively. The method was validated with respect to system suitability, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), robustness and ruggedness The Ondansetron HCL followed linearity in the concentration range of 5-25 µg/mL (r2 = 0.999). The amount of drug estimated by proposed method was found to be in good agreement with label claim. The developed method was validated for sensitivity, accuracy, precision. The LOD and LOQ values were found to be 0.05314 & 0.1610µg respectively for Ondansetron HCL. These data show that method is sensitive for the determination of Ondansetron HCL. The developed method with good symmetry, successfully applied for determination of Ondansetron hydrochloride in its pharmaceutical dosage form
Keyword: HPLC, Ondansetron HCL, C-18, LOD, LOQ, Robustness, Linearity
DOI: https://doi.org/10.31838/ijpr/2021.13.02.159
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