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  Published Paper Details:

  Paper Title

" Analytical Method Development and Validation for Simultaneous Quantification of Tamsulosin HCL and Fexofenadine in Synthetic Mixture By HPLC"

  Authors

  Mr. Aniket Rajesing Girase,  Dr. Javesh Kashinath Patil

  Keywords

RP-HPLC, Tamsulosin HCL, Fexofenadine, Method development, Method validation

  Abstract


This research focuses on creating and validating a HPLC method to concurrently measure Tamsulosin HCL and Fexofenadine in pharmaceutical products. The method development involved optimizing chromatographic conditions using a Symmetry C18 column and a mobile phase composed of Buffer, Methanol, and Acetonitrile (BMA, 50:10:40, pH 5 adjusted with OPA). These conditions resulted in well-defined peaks with satisfactory separation and symmetry for both substances. Validation of the method included assessing linearity over a concentration range of 4+1800 to 12+5400?g/ml for each compound, demonstrating strong correlation coefficients (R^2 > 0.999). Specificity testing confirmed that there were no interferences from excipients, ensuring precise quantification of the drugs. Accuracy studies showed recovery rates between 95-103%, indicating the method's reliability in determining drug concentrations. Precision studies revealed low %RSD values (<2%) for both intra-day and inter-day variability, indicating excellent repeatability and reproducibility. The method's sensitivity was assessed with LODs of 0.36?g/ml for Tamsulosin HCL and 163.75?g/ml for Fexofenadine, and LOQs of 1.08?g/ml and 496.20?g/ml, respectively. The developed RP-HPLC method was successfully applied to analyze a synthetic mixture containing Tamsulosin HCL and Fexofenadine, confirming its suitability for routine quality control analysis in pharmaceutical formulations. Overall, this method provides a reliable approach for accurate and precise quantification of Tamsulosin HCL and Fexofenadine in complex matrices.

  IJCRT's Publication Details

  Unique Identification Number - IJCRT24A6096

  Paper ID - 264728

  Page Number(s) - j837-j848

  Pubished in - Volume 12 | Issue 6 | June 2024

  DOI (Digital Object Identifier) -    http://doi.one/10.1729/Journal.40319

  Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882

  E-ISSN Number - 2320-2882

  Cite this article

  Mr. Aniket Rajesing Girase,  Dr. Javesh Kashinath Patil,   "" Analytical Method Development and Validation for Simultaneous Quantification of Tamsulosin HCL and Fexofenadine in Synthetic Mixture By HPLC"", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.12, Issue 6, pp.j837-j848, June 2024, Available at :http://www.ijcrt.org/papers/IJCRT24A6096.pdf

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ISSN and 7.97 Impact Factor Details


ISSN
ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
ISSN
ISSN and 7.97 Impact Factor Details


ISSN
ISSN
ISSN: 2320-2882
Impact Factor: 7.97 and ISSN APPROVED
Journal Starting Year (ESTD) : 2013
ISSN
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