Author(s):
Divya Shikha, Rohit Bhatia
Email(s):
bhatiarohit5678@gmail.com
DOI:
10.52711/2231-5675.2023.00037 
Address:
Divya Shikha1,2, Rohit Bhatia1*
1Department of Pharmaceutical Analysis, ISF College of Pharmacy, Moga -142001, Punjab, India.
2Department of Pharmacy, Usha Martin University, Angara, Ranchi - 835103, Jharkhand.
*Corresponding Author
Published In:
Volume - 13,
Issue - 4,
Year - 2023
ABSTRACT:
Background: In this work, a novel, simple and accurate reverse phase high-performance liquid chromatographic method with UV detection is presented for the simultaneous estimation of Benidipineand Telmisartan in API and marketed formulations. Objective: To develop and validate this method in accordance to regulatory guidelines i.e. ICH Q2B-R1 for analytical parameters. Methods: In RP-HPLC the separation was achieved using a Xbridge C18 (250x 4.6 i.d; 5µm) column with isocratic elution using a mobile phase consisting of methanol: acetonitrile (80:20v/v/ with 0.1% v/v TEA) adjusted to pH 5.2 with glacial acetic acid at 1mL/min flow for 10min. Benidipine and Telmisartan, were detected at dual wavelength at 237 and 297nm with retention time (Rt) 6.891 and 8.997 minutes respectively. Results: Our new methods (RP-HPLC) were found to (r2>0.999) for both Benidipine and Telmisartan. The developed methods are highly selective, precise and reproducible with %RSD < 2%, Moreover the methods are accurate with recovery more than 99% in both methods. Conclusion: The RP-HPLC method results are efficient, simple and easy. These highly sensitive methods were successfully applied for assay determination of both Benidipine and Telmisartan at fixed dose combination.
Cite this article:
Divya Shikha, Rohit Bhatia. A Validated RP-HPLC Method for Simultaneous Estimation of Benidipine and Telmisartan in Bulk and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(4):231-5. doi: 10.52711/2231-5675.2023.00037
Cite(Electronic):
Divya Shikha, Rohit Bhatia. A Validated RP-HPLC Method for Simultaneous Estimation of Benidipine and Telmisartan in Bulk and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(4):231-5. doi: 10.52711/2231-5675.2023.00037 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-4-1
REFERENCE:
1. Chockalingam, A., N.R. Campbell, and J.G. Fodor. Worldwide epidemic of hypertension. Canadian Journal of Cardiology. 2006; 22(7): 553-555.
2. Van de Vijver, S., et al., Status report on hypertension in Africa-Consultative review for the 6th Session of the African Union Conference of Ministers of Health on NCD’s. Pan African Medical Journal. 2014; 16(1).
3. Gosmanova, E.O., et al., Association of systolic blood pressure variability with mortality, coronary heart disease, stroke, and renal disease. Journal of the American College of Cardiology. 2016; 68(13): 1375-1386.
4. Kokubo, Y. and Y. Iwashima, Higher blood pressure as a risk factor for diseases other than stroke and ischemic heart disease. Hypertension. 2015; 66(2): 254-259.
5. Fuchs, F.D. and P.K. Whelton, High blood pressure and cardiovascular disease. Hypertension. 2020; 75(2): 285-292.
6. Sawai, T., et al., A case of atherosclerotic renal artery stenosis involving successful withdrawal from hemodialysis after percutaneous transluminal renal artery stenting. International Journal of Cardiology. 2016; 223: 669-671.
7. Sakamoto, Y., et al., Effects of calcium channel blockers on renal function, advanced glycation end products (AGEs) and soluble receptor for AGEs in diabetic nephropathy.
8. Yao, K., K. Nagashima, and H. Miki, Pharmacological, pharmacokinetic, and clinical properties of benidipine hydrochloride, a novel, long-acting calcium channel blocker. Journal of Pharmacological Sciences. 2006: 0603240003-0603240003.
9. Tomino, Y., Renoprotective effects of the L-/T-type calcium channel blocker benidipine in patients with hypertension. Current Hypertension Reviews. 2013. 9(2): 108-114.
10. Nishiya, Y., et al., A potent 1, 4-dihydropyridine L-type calcium channel blocker, benidipine, promotes osteoblast differentiation. Calcified Tissue International. 2002; 70(1): 30-39.
11. Smith, D.H. Treatment of hypertension with an angiotensin II—receptor antagonist compared with an angiotensin-converting enzyme inhibitor: A review of clinical studies of telmisartan and enalapril. Clinical Therapeutics. 2002; 24(10): 1484-1501.
12. Investigators. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. The Lancet. 2008; 372(9644): 1174-1183.
13. Wienen, W., et al. A review on telmisartan: a novel, long‐acting angiotensin II‐receptor antagonist. Cardiovascular Drug Reviews. 2000; 18(2): 127-154.
14. Hernández-Hernández, R., et al., Angiotensin II receptor antagonists role in arterial hypertension. Journal of Human Hypertension. 2002; 16(1): S93-S99.
15. Patel, K., D. Shah, and D. Maheshwari, dual wavelength spectrophotometric method for estimation of benidipine hydrochloride and telmisartan in pharmaceutical dosage form. 2018.
16. Patel, B., A. Chaudhary, and S. Gami, RP-HPLC Method Development and Validation for Simultaneous Estimation of Benidipine Hydrochloride, Telmisartan and Chlorthalidone in Tablet. 2019.
17. Naim, M., A. Ahmed, and K. Gj, Stability indicating reverse-phase high-performance liquid chromatography method development and validation for simultaneous estimation of Telmisartan and Benidipine Hydrochloride in pharmaceutical dosage form. Asian J Pharm Clin Res. 2018; 11(5): 342-350.
18. Patel, D.M., et al., Method development and validation for simultaneous estimation of benidipine hydrochloride and metoprolol succinate in tablet. Journal of Drug Delivery and Therapeutics. 2019; 9(6-s): 28-33.
19. Neeli, S., et al., First derivative synchronous spectrofluorimetric quantification of telmisartan/amlodipine besylate combination in tablets. Dhaka University Journal of Pharmaceutical Sciences, 2013; 12(1): 35-40.
20. Mohanbhai, P.L., et al. Spectrophotometric method for the determination of benidipine hydrochloride in pharmaceutical formulation. Tropical Journal of Pharmaceutical and Life Sciences (TJPLS Journal). 2018; 5(1): 01-07.
21. Guideline, I.H.T. ICH topic Q2 (R1) Validation of analytical procedures: text and methodology. in International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. 2005.
22. Magnusson, B., The fitness for purpose of analytical methods: a laboratory guide to method validation and related topics (2014). 2014, Eurachem.