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Background and objectives: This research work make an attempt to establish sensitive and accurate methods for the development and validation of analytical methods for estimation of Remogliflozin Etabonate in bulk and pharmaceutical dosage form.
Methods: A mixture of 0.1% Triethylamine buffer pH 7.9 and methanol in the ratio of 70:30 (v/v%) was used as the mobile phase. A working standard solution of concentration 20 µg/ml was used. An XBridge™ C18 column 5µ (250 mm x 4.6 mm) was used for the analysis at a flow rate of 1 ml/min, injection volume of 20 µl, run time of 10 mins and detection wavelength of 227 nm. The repeatability (within-day in triplicates) and intermediate precision (for two days) were carried out by six injections and the obtained results within and between the days of trials were expressed as % RSD. The linearity of the method was determined by the analysis of analyte concentration across a range of 05μg/ml to 30μg/ml and area was plotted graphically as a function of analyte concentration. The accuracy of the method was determined by calculating recoveries of Remogliflozin Etabonate by the standard addition method. In a pre-quantified sample solution (20µg/ml), a known amount of standard solutions of Remogliflozin Etabonate (80%, 100% and 120%) were added. For robustness a change of ±0.1 ml/min and ±1 nm was done in flow rate and detection wavelength respectively. A signal to noise ratio 3:1 and 10:1 was considered for calculating LOD and LOQ respectively.
Results: The %RSD values of precision studies were found to be below the accepted limit of 2%. The method was found to be linear with a correlation coefficient (r2) of 0.9999. The method was also found to be accurate and robust with suitable values. The LOD and LOQ of the method was found to be 0.42 µg/ml and 1.41 µg/ml respectively.
Interpretation and conclusion: The results of analysis prove that this method can be used for the routine determination of Remogliflozin Etabonate in bulk drug and in pharmaceutical dosage forms.
"New Analytical Method Development and Validation of an RP-HPLC for the Determination of REMOGLIFLOZIN ETABONATE in Bulk and Pharmaceutical Dosage Form", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.7, Issue 10, page no.1014 - 1020, October-2022, Available :http://www.ijrti.org/papers/IJRTI2210124.pdf
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ISSN:
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator