RP-HPLC method development and validation for simultaneous estimation of efonidipine hydrochloride ethanolate and telmisartan in their synthetic mixture
Keywords:RP-HPLC, Efonidipine Hydrochloride Ehanolate and Telmisartan.
A Novel, selective, accurate and rapid Reversed Phase High Performance Liquid Chromatographic (RPHPLC) method for the analysis of Efonidipine Hydrochloride Ethanolate and Telmisartan in binary mixture has been developed and validated. The chromatographic system consisted of a Phenomenex Kinetex ® 5µ C18 Size: 150 * 4.6mm column and the separation was achieved by using ambient temperature with a mobile phase containing mobile Phase Acetonitrile:25mM Phosphate Buffer pH 4.9 (45:55). The samples were monitored at 253 nm for detection at a flow rate of 1.0 mL/min and the retention time was about 7.77 and 4.10 mins for Efonidipine Hydrochloride Ehanolate and Telmisartan respectively. The calibration curve was linear over the concentration range 5-30 and 10-60 ?g/mL for Efonidipine Hydrochloride Ehanolate and Telmisartan respectively. The proposed method is accurate in the range of 99.75% - 100.10% recovery and precise (%RSD of intraday variation and % RSD of inter day variation were found to be within the acceptance criteria). Therefore, this method can be used as a more convenient and efficient option for the analysis of Efonidipine Hydrochloride Ehanolate and Telmisartan in Quality control laboratory.
Walker R., and Whittlesea C. Clinical Pharmacy and Therapeutics; 5th Edn; Elsevier, 295-307, (2012)
Ritter M., Lewis D., and Mant GK. A Textbook of clinical pharmacology and therapeutics; 5th Edn; Great Britain, 185-195, (2008)
Goyal RK. Elements of Pharmacology; 7th Edn; B.S. Shah Prakashan, Ahmedabad, 372-376, (2007)
Beevers G, Lip G and O’Brien E, The pathophysiology of hypertension. British Medicinal Journal. 2001; 322; 912-916.
Kumar A, et al. Development and validation of liquid chromatography (RP-HPLC) methodology for estimation of Efonidipine HCl Ethanolate (EFD). Pharm Anal Acta. 2017; 8(5): 547.
Liu M, et al. A chiral LC-MS/MS method for the spectrospecific determination of Efonidipine in human plasma. J Pharm Biomed Anal. 2016; 122: 35-41.
Otsuka M, et al. Developmental considerations for ethanolates with regard to stability and physicochemical characterization of Efonidipine hydrochloride ethanolate. CrystEngComm. 2015; 00: 1-5.
Liu M, et al. Determination of Efonidipine in human plasma by LC-MS/MS for pharmacokinetic applications. Journal of Pharmaceutical and Biomedical Analysis. 2014; 1-23.
Wang N, Ye L, Zhao B and Yu J, Spectroscopic studies on the interaction of Efonidipine with bovine serum albumin. Braz J Med Biol Res. 2008; 41(7): 589-595.
Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeia Commission, Ghaziabad, Vol. ?, 3319-3320, (2018)
United State Pharmacopoeia 31 National Formulary 26, The United State Pharmacopoeial Convection, Rockville, Vol.-? , 3957-3959, (2011)
European Pharmacopoeia, Council of Europe, Starsbourg cedex; France, Vol. ?, 3369-3370, (2014)
British Pharmacopoeia. Her Majesty’s Stationary Office, London, Vol. ?, 1040-1042, (2018)
Kumar M, et al. Dissolution method development and validation for tablet dosage form of Telmisartan using UV spectrophotometric method. J. Chem. Pharm. Res. 2018; 10(5): 148-156.
Deshmukh T, Deo S and Inam F, Simultaneous Estimation of Atorvastatin Calcium and Telmisartan in tablet dosage form by spectrophotometry. IJPPR. 2018; 11(2): 46-48.
Deshmukh T, Deo S and Inam F, Development and method validation of Atorvastatin Calcium and Telmisartan in tablet dosage form by RP-HPLC method. J Pharm Chem Biol Sci. 2018; 5(4): 16-24.
Barge V, Gaikwad R, Chaudhari F and Kande T, Development and validation of analytical method for simultaneous estimation of Bisoprolol Fumarate and Telmisartan by using RPHPLC method. IJPCR. 2018; 10(8): 219-223.
Sivkamasundari G and Kannappan N, Method development and validation for simultaneous estimation of Chlorthalidone, Telmisartan and Amlodipine by RP-UPLC in pharmaceutical dosage form. Int. J. Res. Pharm. Sci.2018; 9(3): 686-690.
Alhazmi H, et al. A fast and validated reversed-phase HPLC method for simultaneous determination of Simvastatin, Atorvastatin, Telmisartan and Irbesartan in bulk drugs and tablet formulations. Sci. Pharm. 2018; 86(1): 1-13.
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