Novel Analytical Method Development and Validation for Simultaneous Estimation of Rosuvastatin and Bempedoic acid in Marketed Formulation using RP-HPLC

Dr. Vandana Jain , Binita Singh

Rosuvastatin; Bempedoic acid; UV detection; Simultaneous estimation; Method development; RP-HPLC; Novel.

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.

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"Novel Analytical Method Development and Validation for Simultaneous Estimation of Rosuvastatin and Bempedoic acid in Marketed Formulation using RP-HPLC", IJSDR - International Journal of Scientific Development and Research (www.IJSDR.org), ISSN:2455-2631, Vol.8, Issue 7, page no.756 - 762, July-2023, Available :https://ijsdr.org/papers/IJSDR2307109.pdf

Volume 8 Issue 7, July-2023

Pages : 756 - 762

Paper Reg. ID: IJSDR_207701

Published Paper Id: IJSDR2307109

Downloads: 000347405

Research Area: Pharmacy

Country: -, -, -

Published Paper PDF: https://ijsdr.org/papers/IJSDR2307109

Published Paper URL: https://ijsdr.org/viewpaperforall?paper=IJSDR2307109

DOI: http://doi.one/10.1729/Journal.35238

ISSN: 2455-2631 | IMPACT FACTOR: 9.15 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 9.15 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJSDR(IJ Publication) Janvi Wave

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