Manisha Masih, Abhilasha Mittal, B.C. Nandy, Development and Validation of HPLC Method for Simultaneous Estimation of Amlodipine Besylate and Lisinopril DihydrateiIn Solid Dosage Form, ASIO Journal of Analytical Chemistry (ASIO-JAC), 2015, 1(1): 33-37.
ARTICLE TYPE: RESEARCH
dids no.: 03.2016-28554435,
dids link: http://dids.info/didslink/03.2016-64176365/
A rapid, sensitive and specific HPLC method involving UV detection was developed and validated for determination and quantification of Amlodipine besylate and Lisinopril dihydrate in tablet dosage form. The determination was carried out on a Phenomenex C18 (250 x 4.6 mm, 5 μm) column using filtered and degassed mixture of methanol: 1N HCl (1:1) as mobile phase at a flow rate of 1 ml/min and effluent was monitored at 230 nm. The retention time for Amlodipine besylate was 4.20 min and for Lisinopril dihydrate 2.76 min. Amlodipine besylate and Lisinopril dihydrate showed a linear response in the concentration range of 10-50μg/ml. The correlation co-efficient ('r' value) for Amlodipine besylate and Lisinopril dihydrate was 0.9997 and 0.9989, respectively. The method was validated in terms of linearity, precision, accuracy, specificity, robustness and solution stability. The proposed method can be useful in the quality control of bulk manufacturing and pharmaceutical dosage forms.
Keywords: Amlodipine besylate, Lisinopril dihydrate, Method development, Validation, HPLC.
- Indian Pharmacopoeia, published by the controller of publication: New Delhi: 2014; II: p.1045-1047.
Wilson and Grisvold’s. Organic Medicinal and Pharmaceutical chemistry ed. by John H. Block and John M.Beale, Wolters Kluwer, London: UK: 2004; pp. 631.
- KD Tripathi Essentials of Medical Pharmacology, 5th ed.; Jaypee Brothers Medical Publishers, 2004.pp.496.
- G Garg, S Saraf, and S Saraf, Development and validation of simultaneous estimation of Enalapril maleate and Amlodione Besylate in combined dosage forms. Trends in App Sci Res, 2008, 3(3), 278-284.
- Indian Pharmacopoeia, published by the controller of publication: New Delhi: 2014; II: p.2105-2107.
- Wilson and Grisvold’s Textbook Organic Medicinal and Pharmaceutical chemistry edited by John H. Block and John M. Beale, Wolters Kluwer, London : UK: 2004; p. 645-646.
- KD Tripathi, Essentials of Medical Pharmacology 5th ed. Jaypee Brothers Medical Publishers; 2004; p.450-451.
- P Rathee, S Rathee, S Thakur, V Kumar, Simultaneous estimation of Amlodipine Besylate and Lisinopril Dihydrate as A.P.I. and in tablet dosage forms by modified form of simultaneous equation method using derivative UV- Spectrophotometry. Int J of Pharm Tech Res, 2010, 2(1), 556-562.
- HV Joshi and JK Patel, New Spectrophotometric methods for simultaneous determination of amlodipine besylate and lisinopril in tablet dosage forms. J of App Pharma Sci, 2011, 1(6), 162-164.
- V Chauhan, ST Prajapati, CN Patel. A Validated RP-HPLC method for simultaneous estimation of amlodipine and lisinopril in pharmaceutical dosage form. Int J of Pharma Sci Res, 2011, 2(7), 1712-1715.
- VR Bhaskara, AL Rao. Novel Validated RP-HPLC method for the simultaneous estimation of lisinopril and amlodipine in bulk and tablet dosage form. Int J Pharma, Chem Bio Sci, 2011, 1(1), 32-37.
- KH Gopani, SS Havele, SR Dhaneshwar Application of High Performance Thin Layer Chromatography Densitometry for the simultaneous determination of amlodipine besylate and lisinopril in bulk drug and tablet formulation. Int J Pharma Tech, 2011, 3(2), 2353-2367.
- ICH Harmonised Tripartite Guidelines, Validation of analytical procedures: text & methodology, Q2 (R), 2005.