H. Padma Latha,
S. Deepa,
CH. Sri Divya,
S. Raja Sree,
G. Aruna,
- Professor, Department of pharmaceutics, Gyana Jyothi College of Pharmacy, Hyderabad, Telangana, India
- Associate Professor, Department of pharmaceutics, Gyana Jyothi College of Pharmacy, Hyderabad, Telangana, India
- Associate Professor, Department of pharmaceutics, Gyana Jyothi College of Pharmacy, Hyderabad, Telangana, India
- Associate Professor, Department of pharmaceutics, Gyana Jyothi College of Pharmacy, Hyderabad, Telangana, India
- Associate Professor, Department of pharmaceutics, Gyana Jyothi College of Pharmacy, Hyderabad, Telangana, India
Abstract
A straightforward, precise method was developed to simultaneously assess Bempedoic acid and Rosuvastatin in both bulk and tablet forms. Utilizing a DIKMA Spursil C18 column (4.6 mm x 250 mm, 3.0 μm), chromatography was conducted with a mobile phase comprising 30% phosphate buffer and 70% acetonitrile, flowing at 1 ml/min. Operating at ambient temperature, the optimized wavelength for detection was set at 240 nm, revealing retention times of 4.418 min for Bempedoic acid and 3.524 min for Rosuvastatin. Both compounds exhibited high purity levels, with Bempedoic acid at 100.57% and Rosuvastatin at 100.15%. The system’s suitability parameters, such as theoretical plates and tailing factor, fell within acceptable thresholds at 4402.39 and 6959.54, respectively, with values of 1.12 and 3.60.Linearity studies demonstrated strong correlation coefficients (r2) of 0.999 for both Bempedoic acid and Rosuvastatin, with mean recovery percentages of 100.33% and 100.74%, respectively. Repeatability showed low % RSD values of 1.0 and 0.3, while intermediate precision displayed % RSD values of 0.7 and 1.2, respectively. Overall, the precision study affirmed the method’s reliability, robustness, and repeatability. These findings validate the proposed RP‐HPLC method as a dependable, rapid, and reproducible technique suitable for routine estimation of Bempedoic acid and Rosuvastatin in both bulk and tablet forms.
Keywords: Bempedoic acid, Rosuvastatin, RP‐HPLC, Simultaneous estimation.
[This article belongs to Research & Reviews: A Journal of Toxicology (rrjot)]
H. Padma Latha, S. Deepa, CH. Sri Divya, S. Raja Sree, G. Aruna. Toxicology-Focused Development and Validation of an RP-HPLC Technique for Quantifying Bempefoic Acid and Rosuvastatin in a Fixed-Dose Combination. Research & Reviews: A Journal of Toxicology. 2024; 14(02):1-9.
H. Padma Latha, S. Deepa, CH. Sri Divya, S. Raja Sree, G. Aruna. Toxicology-Focused Development and Validation of an RP-HPLC Technique for Quantifying Bempefoic Acid and Rosuvastatin in a Fixed-Dose Combination. Research & Reviews: A Journal of Toxicology. 2024; 14(02):1-9. Available from: https://journals.stmjournals.com/rrjot/article=2024/view=156741
References
1.Saeed A, Ballantyne CM: Bempedoic Acid (ETC-1002): A Current Review. Cardiol Clin. 2018 May;36(2):257-264. doi: 10.1016/j.ccl.2017.12.007. Epub 2018 Feb 21. 2. Bilen O, Ballantyne CM: Bempedoic Acid (ETC-1002): an Investigational Inhibitor of ATP Citrate Lyase. Curr Atheroscler Rep. 2016 Oct;18(10):61. doi: 10.1007/s11883-016-0611-4. 3. Zagelbaum NK, Yandrapalli S, Nabors C, Frishman WH: Bempedoic Acid (ETC-1002): ATP Citrate Lyase Inhibitor: Review of a First-in-Class Medication with Potential Benefit in StatinRefractory Cases. Cardiol Rev. 2019 Jan/Feb;27(1):49-56 4. Di Napoli P, Taccardi AA, Grilli A, De Lutiis MA, Barsotti A, Felaco M, De Caterina R: Chronic treatment with rosuvastatin modulates nitric oxide synthase expression and reduces ischemiareperfusion injury in rat hearts. Cardiovasc Res. 2005 Jun 1;66(3):462-71. Epub 2005 Mar 2. [Article] 5. Everett BM, Glynn RJ, MacFadyen JG, Ridker PM: Rosuvastatin in the prevention of stroke among men and women with elevated levels of C-reactive protein: justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER). Circulation. 2010 Jan 5;121(1):143-50. doi: 10.1161/CIRCULATIONAHA.109.874834. Epub 2009 Dec 21. [Article] 6. Jones SP, Gibson MF, Rimmer DM 3rd, Gibson TM, Sharp BR, Lefer DJ: Direct vascular and cardioprotective effects of rosuvastatin, a new HMG-CoA reductase inhibitor. J Am Coll Cardiol. 2002 Sep 18;40(6):1172-8. [Article] 7. Uma Sai Teja Yarra and Sowjanya Gummadi: Stability indicating RP-HPLC method for simultaneous quantification of bempedoic acid and ezetimibe in bulk and pharmaceutical formulations. Future Journal of Pharmaceutical Sciences 2021; 209. 8. Anuradha Vijender, Subrahmanyam Talari, G. Ramu and Rajani CH: Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using HPLC: development and validation of stability-indicating UPLC method Future J of Pharma Sciences 2021; 234. 9. Fatima Hussain Bayzeed and Ayesha Begum Khadernaick: A new validated RP-HPLC method for the analysis of Bempedoic acid and Ezetimibe in bulk drug samples. International journal of Pharmacy and Analytical Research 2020; 9(4): 248-252. 10. Divya Molleti, Krishnamanjari P. Amgoth and Sushma Pallekona: Stability indicating method development and validation for the estimation of bempedoic acid and ezetimibe by RP-HPLC. International Journal of Pharmaceutical Science and Drug Research 2021; 13(5): 559-564.
Research & Reviews: A Journal of Toxicology
Volume | 14 |
Issue | 02 |
Received | 26/03/2024 |
Accepted | 02/04/2024 |
Published | 20/07/2024 |