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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: | Novel Analytical Method Development and Validation for Simultaneous Estimation of Rosuvastatin and Bempedoic acid in Marketed Formulation using RP-HPLC |
| Authors Name: | Dr. Vandana Jain , Binita Singh |
| Unique Id: | IJSDR2307109 |
| Published In: | Volume 8 Issue 7, July-2023 |
| Abstract: | The aim of the study is to develop an straight forward, precise, accurate, reliable and optimised method for the simultaneous estimation of Rosuvastatin and Bempedoic acid in the pharmaceutical formulation and the method was subsequently validated in accordance with the ICH guidelines. The suggested technique is based on the reversed phase mode separation of the two drugs using Shimadzu's C18 (250x4.6 mm, 5µm ) column. The drugs were separated using the isocratic elution method with a mobile phase composed of phosphate buffer(pH 4):acetonitrile (40:60v/v) at a flow rate of 1.5 mL/min and 20 µL injection volume. UV detection was carried out at 215 nm while maintaining a column temperature at 40 °C. The procedure was approved in accordance with the ICH standards. Using the optimised technique, peak retention times of Rosuvastatin and Bempedoic acid was found to be 2.6 min and 4.1 min respectively. Both Rosuvastatin and Bempedoic acid had linearities and ranges of 20–60 µg/mL (R²=0.9965) and 90–270 µg/mL (R²=0.9947), respectively. When known amount of a reference drug were added to the pre-analyzed test solution for recovery test, the accuracy of the method was found to be 100.15% for Rosuvastatin and 99.85% for Bempedoic acid. Both precision and robustness study found to have % RSD values of less than 2. Thus, the suggested method can be successfully used in routine analysis for the simultaneous determination of Rosuvastatin and Bempedoic acid in dosage form. |
| Keywords: | Rosuvastatin; Bempedoic acid; UV detection; Simultaneous estimation; Method development; RP-HPLC; Novel. |
| Cite Article: | "Novel Analytical Method Development and Validation for Simultaneous Estimation of Rosuvastatin and Bempedoic acid in Marketed Formulation using RP-HPLC", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 7, page no.756 - 762, July-2023, Available :http://www.ijsdr.org/papers/IJSDR2307109.pdf |
| Downloads: | 000338536 |
| Publication Details: | Published Paper ID: IJSDR2307109 Registration ID:207701 Published In: Volume 8 Issue 7, July-2023 DOI (Digital Object Identifier): http://doi.one/10.1729/Journal.35238 Page No: 756 - 762 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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