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Development and Validation of RP-HPLC Method for Estimation of Ondansetron HCL in Bulk and Pharmaceutical Dosage Form
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| Author:
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, 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
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| Abstract:
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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
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| Keyword:
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HPLC, Ondansetron HCL, C-18, LOD, LOQ, Robustness, Linearity
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.159
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| Download:
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