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“Stability Indicating RP-HPLC Method Development and Validation for the Estimation of Remogliflozin Etabonate in Bulk and Pharmaceutical Dosage Form”
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| Author:
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TUSHAR BHATKAR, AMOL V. BADKHAL, NITIN S. BHAJIPALE
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| Abstract:
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A simple, fast, and highly selective RP-HPLC method was developed for the determination of remogliflozin etabonate in API and tablet dosage form. The separation was done by using Agilent technology HPLC. Column Agilent C18 (250mm × 4.6 mm) with Mobile Phase was Methanol : 0.1% Ortho phosphoric acid (80:20% v/v). The flow rate was 0.9ml/min, and the analytes were measured at ?max 227 nm. The retention time for remogliflozin etabonate was 4.881 min, 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. Linearity studies was performed (10–60µg/ml), LOD and LOQ was found to be 0.2201 and 0.6669 µg/ml respectively. The relative standard deviation for accuracy was found to be less than 2 %. The mean percentage recovery was 99.50% to 100.12 %.The forced degradation studies were carried out by using 0.01N NaOH, 1.0 N HCl, 3 % H2O2. Deprivation performance shows that the major deprivation was observed at basic condition i.e. NaOH (5.06 %) followed by HCl (4.71%), H2O2 (4.04%) and Thermal (5.45) respectively.
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| Keyword:
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Remogliflozin etabonate, Methanol, RP-HPLC, Method development, Validation, Forced degradation.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.04.026
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| Download:
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