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INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016 open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15 |
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| Paper Title: | Development and Validation of a Method for Simultaneous Determination of Silodosin and Dutasteride in a Formulation by RP-HPLC |
| Authors Name: | Dipak K. Narale , Ashpak M. Tamboli , Mahesh N. Pingale , Ranjeet P. Vibhute |
| Unique Id: | IJSDR2308018 |
| Published In: | Volume 8 Issue 8, August-2023 |
| Abstract: | Silodosin and Dutasteride both are approved drugs by USFDA (Food & Drug Administration). On literature survey, it was found that no methods have been reported for simultaneous estimation of Silodosin and Dutasteride. Therefore, it was thought of interest to develop a simple, accurate, precise, sensitive and economic analytical method and to validate as per ICH guidelines. So, RP-HPLC method was developed and validated for simultaneous estimation of Silodosin and Dutasteride in multiunit system. Separation was achieved on Agilent technology HPLC; Agilent Zorbax Bonus RP (250 x 4.6 mm, 5 µ) at 30°C temperature by using a mobile phase Buffer: Methanol in the ratio of 50:50. Analysis was done at the flow rate of 1.0 mL/min and UV detection was carried out by wavelength gradient at 235 nm (0 to 5 min.). The retention time of Silodosin and Dutasteride was found to be 4.01 min & 7.29 min respectively. The specificity of the method was determined by assessing interference from placebo. The method was validated in terms of linearity, precision, accuracy, specificity, robustness, ruggedness, solution stability. The linearity was found to be in the range of 128- 192 μg/mL & 8-12 μg/mL for Silodosin and Dutasteride with correlation coefficient of 0.9998for Silodosin and 0.9994 for Dutasteride. %RSD of method precision was found to be less than 2%, this indicates that the method is precise. |
| Keywords: | Silodosin, Dutasteride, RP-HPLC, validation, method development |
| Cite Article: | "Development and Validation of a Method for Simultaneous Determination of Silodosin and Dutasteride in a Formulation by RP-HPLC", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 8, page no.123 - 133, August-2023, Available :http://www.ijsdr.org/papers/IJSDR2308018.pdf |
| Downloads: | 000338720 |
| Publication Details: | Published Paper ID: IJSDR2308018 Registration ID:208045 Published In: Volume 8 Issue 8, August-2023 DOI (Digital Object Identifier): Page No: 123 - 133 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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