A Stability Indicating RP-HPLC Method Validation for simultaneous estimation of Azelnidipine and Telmisartan in a fixed-dose combination
Abstract
The present investigation deals with the validation of the developed method using RP-HPLC for simultaneous estimation of Azelnidipine as well as Telmisartan in a fixed-dose combination (FDC). The method was developed using RP-HPLC, Inertsil C-18 Column with 150×4.6 mm× 5 µm at column oven temperature 40°C, flow rate 1.5 mL/min, volume 10 µL and run time 12.0 minutes at 254 nm using Acetonitrile and buffer as mobile phase in various ratio. The developed protocol was most accurate, repeatable, and detectable towards Azelnidipine and Telmisartan in combination without any unwanted interference. When evaluated on various parameters like system suitability, precision, accuracy, linearity, robustness, force degradation study it can be concluded that the method is efficient in separating the API from its degradants and can be utilized for analyzing the samples of Azelnidipine and Telmisartan.
Keywords:
Azelnidipine, Telmisartan, RP HPLC, Method Validation, Stability.DOI
https://doi.org/10.25004/IJPSDR.2021.130308References
Rowan CG, Turner JR, Shah A, Spaeder JA. Anti-hypertensive treatment and blood pressure control relative to hypertension treatment guidelines. Pharmacoepidemiology and drug safety. 2014; 23(12):1294-1302.
Ram CV. Fixed-dose triple-combination treatment s in the management of hypertension. Managed Care (Langhorne, Pa.). 2013; 22(12):45-55.
Chrysant SG. Using fixed-dose combination therapies to achieve blood pressure goals. Clinical drug investigation. 2008; 28(11):713- 734.
Wan X, Ma P, Zhang X. A promising choice in hypertension treatment: Fixed-dose combinations. asian journal of pharmaceutical sciences. 2014;9(1):1-7.
Koike H. Azelnidipine, a long-acting calcium channel blocker with slow onset and high vascular affinity. Annu Rep Sankyo Res Lab. 2002;54:1-64.
Segura J, Ruilope LM. Clinical utilit y of fixed-combination telmisartan–amlodipine in the treatment of hypertension. Integrated blood pressure control. 2011;4:27.
Oizumi K, Nishino H, Koike H, Sada T, Miyamoto M, Kimura T. Anti-hypertensive effects of CS-905, a novel dihydropyridine Ca++ channel blocker. The Japanese Journal of Pharmacology. 1989;51(1):57-64.
Nakamoto M, Ohya Y, Sakima A, Yamazato M, Takishita S. Azelnidipine attenuates cardiovascular and sympathetic responses to air-jet stress in genetically hypertensive rats. Hypertension research. 2007;30(4):359-66.
Jinno T, Iwai M, Li Z, Li JM, Liu HW, Cui TX, Rakugi H, Ogihara T, Horiuchi M. Calcium channel blocker azelnidipine enhances vascular protective effects of AT1 receptor blocker olmesartan. Hypertension. 2004;43(2):263-9.
Selvadurai Muralidharan, Subramaniya Parasuraman and Vijayan Venugopal.Simple Validation of Azelnidipine by RP-HPLC Method. Rapports De Pharmacie. 2015(1);43-45.
Patel N, Patel J. Simultaneous determination of azelnidipine and olmesartan medoxomil by first derivative spectrophotometric method. Der Pharmacia Lettre. 2012;4(4).
Pan YF, Zhang JB, Ding J, Wang TM. Determination of azelnidipine tablets by HPLC. Qilu Pharmaceutical Affairs. 2008;7:398-3999.
An H-M, Wang J-C. Determination of content and related substances of Azelnidipine by HPLC. West China J Pharm Sci. 2006; 06.
Kawabata K, Urasaki Y. Simultaneous determination of azelnidipine and two metabolites in human plasma using liquid chromatography-tandem mass spectrometry. Journal of Chromatography B. 2006;844(1):45-52.
Ding L, Chen Y, Yang L, Wen A. Determination of palonosetron in human plasma by liquid chromatography–electrospray ionization-mass spectrometry. Journal of pharmaceutical and biomedical analysis. 2007;44(2):575-80.
Jia J, Nan F, Liang MZ, Yu Q, Qin YP, Xiang J. Determination and pharmacokinetics of azelnidipine in human plasma by HPLC-MS-MS. Chin J Hospital Pharmacy. 2010;24.
Patel N, Patel J. Simultaneous determination of azelnidipine and olmesartan medoxomil by first derivative spectrophotometric method. Der Pharmacia Lettre. 2012; 4(4).
Deppe S, Böger RH, Weiss J, Benndorf RA. Telmisartan: a review of its pharmacodynamic and pharmacokinetic properties. Expert opinion on drug metabolism andtoxicology. 2010;6(7):863-71.
Palled MS, Rajesh PN, Chatter M, Bhat AR. RP-HPLC determination of telmisartan in tablet dosage forms. Indian journal of pharmaceutical sciences. 2005;67(1):108.
Xu M, Song J, Liang Y. Rapid determination of telmisartan in pharmaceutical preparations and serum by linear sweep polarography. Journal of Pharmaceutical and Biomedical analysis. 2004;34(3):681-7.
Haritha P, Rao BS, Naganjaneyulu B, Sunandamma Y. Simultaneous Determination of Hydrochlorothiazide and Telmisartan by Using Reverse Phase HPLC Technique. Journal of Applicable Chemistry. 2014;3(1):139-50.
Dasbiswas A, Tamboli T, Ingole S, Naik S, Jain R. Management of hypertension-Insights into real-world clinical practice for differential usage of calcium channel blockers (CCBS). J Evid Based Med Healthc.. 2017;4(38):2295-2299.
Wellington K, Scott LJ. Azelnidipine. Drugs. 2003;63(23):2613-2621.
Oparil S, Weber M. Angiotensin receptor blocker and dihydropyridine calcium channel blocker combinations: an emerging strategy in hypertension therapy. Postgraduate medicine. 2009;121(2):25-39.
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