Volume : 12, Issue : 03, March – 2025

Title:

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR AMLODIPINE BESYLATE USING RP-HPLC

Authors :

Shubhangi Ravindra Thamke and Chandrasekhar K Gadewar

Abstract :

Amlodipine Besylate is a calcium channel blocker commonly prescribed for the management of hypertension and angina pectoris. Accurate and reliable analytical methods are essential for quality control in pharmaceutical formulations. This study focuses on the development and validation of a novel High-Performance Liquid Chromatography (HPLC) method for the quantitative estimation of Amlodipine Besylate in tablet dosage forms. The chromatographic separation was achieved using a C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase consisting of phosphate buffer (pH 3.0) and acetonitrile in the ratio of 65:35 v/v, at a flow rate of 1.0 mL/min. Detection was carried out at 238 nm using a UV detector. The method was validated according to ICH Q2 (R1) guidelines, covering parameters such as linearity, accuracy, precision, specificity, robustness, and system suitability. The linearity of the method was established in the range of 10–60 µg/mL with a correlation coefficient (R²) of 0.999. The method demonstrated acceptable accuracy (recovery between 98.5%–101.5%), precision (RSD < 2%), and robustness under varied experimental conditions. The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.53 µg/mL and 1.61 µg/mL, respectively. The developed HPLC method proved to be simple, sensitive, precise, and suitable for routine analysis of Amlodipine Besylate in pharmaceutical dosage forms.
Keywords: Amlodipine Besylate, HPLC, Method Development, Validation, ICH Guidelines, Tablet Dosage Form

Cite This Article:

Please cite this article in press Shubhangi Ravindra Thamke and Chandrasekhar K Gadewar., Analytical Method Development And Validation For Amlodipine Besylate Using RP-HPLC., Indo Am. J. P. Sci, 2025; 12(05).

Number of Downloads : 10

References:

1. Amrish Sharma, Mukul Tailang, Bhaskar Gupta and Ashish Acharya, RP HPLC Determination of Amlodipine in Its Pharmaceutical Dosage Forms (129), Asian Journal of Research In Chemistry, Volume 03, Issue 01, January-February, 2010(ISSN 0974-4169).
2. Carr GP, Wahlich JC. A practical approach to method validation in pharmaceutical analysis. Journal of Biomedical Analysis, 86(8), 1990, 613-618.
3. Skoog DA, Holler J and Nieman TA, Principle of Instrumental Analysis, 5th edition, Saunders College Publishing 1998, 778-787
4. DA Shah, KK Bhatt, MB Shankar, RS Mehta, TR Gandhi, SL Baldania, RP-HPLC determination of atorvastatin calcium and amlodipine besylate combination in tablets.
5. FDA, Analytical Procedures and Methods Validation: Chemistry, Manufacturing and Controls Documentation; Availability, Federal Register (Notices), 65(169), 2000, 52776–52777. 8. Gurdeep Chatwal, Sahm K, Anand, Instrumental methods of Chemical Analysis, 5th edition, Himalaya publishing house, New Delhi, 1, 2002, 1-1.8, 2.566- 2.570.
6. Lakshmi B. RP-HPLC method development for the quantification of gabapentin in formulations. Exp Int J Sci Technol 2012; 2:84-92.
7. CV, Patel PB. Development and validation of analytical methods for simultaneous estimation of amitriptyline hydrochloride and methylcobalamin in their tablet dosage form by UV spectrophotometric method. Pharma Tutor Mag 2015; 3:46-50.
8. Galande VR, Baheti KG, Dehghan MH. UV-visible spectrophotometric method for estimation of gabapentin and methylcobalamin in bulk and tablet. Int J Chem Tech Res 2010; 2:695-9.
9. Chung Chow Chan, Y.C. Lee, Herman Lam, Xue – Ming Zhang,1st edition, Analytical Method Validation and Instrument Performance Verification, Wiley and Son, Canada,2004, 35-45
10. ICH Topic Q2A, “Validation of Analytical Procedures”: Text, 6th Nov 1996,
11. Brahmi, Journal of chromatography B, Volume 1-2, 11(5), 826, 2005
12. B.V.S Lokesh, Eastern pharmacist, vol no-458, 1996, 125-126.
13. B.V.V. Ravi Kumar, P.K. Singh, K.E.V. Nagoji, M.E.B. Rao, A. Raj and G. Madhavi, Scientific Abstracts, 2006: 289.
14. Dhorda, U.J wala, Indian drugs,36(10) ,1999, 638-641.
15. Ertwk, Esra Sevic Akta, Lale Ersoy and Samiye, Journal of Pharmaceutical and Biomedical Analysis, Volume 33, 2003: 1017-1023.
16. Kaliappan, Indian drugs 37 (10) October 2000. 497-499
17. Maleuski.MD, Journal of Analytical Chemistry, volume 89(2), 2006, p no-359-364.
18. Shen, Pubmed, vol 61, issue: 1,2006, 18-20.
19. Lamba H.S, Manuvesh Sangwan, Varun Arora, Arvind Rathour, Indian Journal of Pharmaceutical Sciences, 2006, Pg. No: 75.
20. Nilesh Jain. M.R. Khan and Deepti Jain, Indian Journal of Pharmaceutical Sciences, 2006, 75.