Volume : 12, Issue : 08, August- 2025
Title:
A NEW ANALYTICAL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF CILNIDIPINE IN BULK AND MARKETED PHARMACEUTICAL DOSAGE FORM
Authors :
Kurni Lakshmi Deepthi*, Kundhavaram Sai Sree, Muddagouni Sneha, Adepu Shruthi2, Vatti Sravya, Katroth Pavani, Medapati Akshitha, Marla Manasa
Abstract :
A novel, simple, accurate, precise, sensitive and specific analytical RP-HPLC method was developed and validated for the quantitative estimation of Cilnidipine in bulk drugs and pharmaceutical dosage form. Chromatographic separation was achieved on a Symmetry ODS C18 (4.6×250mm, 5µm) analytical column using mobile phase composition of methanol and Phosphate Buffer in ratio of (35: 65 v/v) that was set at a flow rate of 1.0μl/min with detection of 235 nm. The retention time of Cilnidipine was found to be 3.006min. The drug was analyzed by following the guidelines of International conference on Harmonization (ICH). This drug showing linearity in the concentration range of 6-14µg/ml and the correlation coefficient showing R2 = 0.9996. The % Recoveries showing within the limits. The presentation of the method was validated according to the present ICH guidelines for accuracy, precision and robustness, Linearity, limit of quantification, limit of detection linearity.
Key Words: Cilnidipine, RP-HPLC, Method Development, Accuracy, Precision
Cite This Article:
Please cite this article in press Kurni Lakshmi Deepthi et al A New Analytical Rp-Hplc Method Development And Validation For The Quantitative Estimation Of Cilnidipine In Bulk And Marketed Pharmaceutical Dosage Form., Indo Am. J. P. Sci, 2025; 12(08).
Number of Downloads : 10
References:
1. https://go.drugbank.com/drugs/DB09232
2. https://pubchem.ncbi.nlm.nih.gov/compound/Cilnidipine
3. https://en.wikipedia.org/wiki/Cilnidipine
4. R. Snyder, J. Kirkland, L. Glajch, Practical HPLC Method Development, john Wiley and sons International publication, II Edn., 2011.
5. S. Ashutoshkar, Pharmaceutical Drug Analysis 2nd Edn, New Age International Private Limited Publishers, 452-474, 2005.
6. H. Beckett and J.B. Stenlake, Practical Pharmaceutical Chemistry, 4th End. C.B.S. Publishers and Distributors’, New Delhi. 1-9, 157-167.
7. H.H. Williard, L.L. Merit, F.A. Dean, F.A. Settle, Instrumental Methods Of Analysis, 6th Edn, C.B.S. Publishers and Distributors, New Delhi.: 430-440, 495-504,529-545.
8. B.K. Sharma, Instrumental Methods of Chemical Analysis. GOEL Publishing House, Meerut: 286-300.
9. Instant notes on analytical chemistry by D. Kealey and P.J. Haines, © BIOS Scientific Publishers Limited, UK, 6-7, 2002.
10. Gurdeep R. Chatwal, Sham K. Anand, Instrumental methods of Chemical Analysis,5th edition, Himalaya Publishing House(Mumbai), P-2.566, 2005,.
11. M. E. Swartz, Journal of liquid chromatography, 28(7/8), 1253-1263(2005).
12. Journal of Chromatography .B, Analytical Technologies in the Biomedical and life Sciences. 2008 March 1; 863(2): 258-265. Published on Jan 18 2008.
13. International Conference on Harmonization, Harmonized Tripartite Guideline. Validation of Analytical Procedures. Text and Methodology. Q2 (R1). November 2005.
14. International Conference on Harmonization (ICH). Validation of Analytical Methods: Definitions and Terminology. ICH Q2A. 1994.
15. J. M. Green, a practical guide to analytical method validation, anal. Chem. News & features, pp. 305a–309a, 1 May 1996.
16. P. A. Winslow and r. F. Meyer, defining a master plan for the validation of analytical methods, j. Validation technology, pp. 361–367, 1997.
17. Aoac peer-verified methods program, manual on policies and procedures, Arlington, Va., USA (1998).
18. R. Patil: J of Chromatographia, 67, 575, (2008).
19. Baht and Leena: J of Liq. Chrom., 30, 309, (2007).
20. H.H. Williard, L.L. Merit, F.A. Dean and F.A. Settle, Instrumental methods of analysis, 7th edition, C.B.S. Publishers, New Delhi, 2002.
21. GN Menon, LB White, Department of Analytical Research, Abbott Laboratories, (pub med-index for MEDLINE).
22. Food and Drug Administration (FDA), “Analytical Procedures and Methods Validation: Chemistry, Manufacturing and Controls Documentation;” Federal Register (Notices), Vol:65 (169), 52776–52777, 2000.
23. Vibha G et al., Development and validation of HPLC method – a review. International Research Journal of Pharmaceutical and Applied Sciences. 2012, 2(4), 22-23.
24. Bliesner DM. In: Validating Chromatographic Methods. John Wiley & sons Inc. 2006, 88-92.
25. Validation of Analytical Procedures: Methodology. ICH-Guidelines Q2B, Geneva. 1996, 11. (CPMP/ICH/281/95).
26. Development and validation of HPLC method – A Review, Vibha Gupta et al, International Research Journal of Pharmaceutical and Applied Sciences, 2012; 2(4):17-25.
27. A Review: HPLC Method Development and Validation, Santosh Kumar Bhardwaj *et al. International Journal of Analytical and Bioanalytical Chemistry, accepted 20 November 2015.
28. Method Development: A Guide to Basics Quantitative & Qualitative HPLC, LC, GC chromacademy.
29. Lalit V Sonawane* Bioanalytical Method Validation and Its Pharmaceutical Application- A Review Pharmaceutica Analytical Acta 2014, 5:3Center for Drug Evaluation and Research (CDER) Reviewer Guidance.
30. ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology.
31. P. Ravi Sankar *, V. Swathi and P. Srinivasa Babu, Development and Validation of Novel UV and RP-HPLC Methods for Determination of Cilnidipine (A New Generation Ca Channel Blocker) In Pharmaceutical Dosage Form, International Journal of Pharmaceutical Sciences and Research, IJPSR, 2019; Vol. 10(4): 1886-1894.
32. Tiwari Balakrishna 1*, Shirsat Mrunal K.2, Kulkarni Amol 3, Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Cilnidipine, Journal of Drug Delivery & Therapeutics. 2020; 10(1):97-100.
33. Ruhina Tanweer*, T. Mamatha, A Novel RP HPLC Method for Development and Validation of Cilnidipine in Bulk and Pharmaceutical Dosage Form, Asian Journal of Pharmaceutical Technology & Innovation, 05 (14); 2017; 72 -81.
34. A. Kadam, P. Hamrapurkar, S. Patil, M. Manoharan, Development and validation of stability indicating RP-HPLC method for the estimation of Cilnidipine in bulk and pharmaceutical dosage form, January 2015International Journal of Pharmaceutical Sciences Review and Research 30(1):177-181.
35. Prajapati Ketulkumar M.*, Bhumi Patel, Jaymin Patel, Dr. Vinay Darji, Jatinkumar D. Raja, Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Cilnidipine and Irbesartan in Its Pharmaceutical Dosage Form, World Journal of Pharmacy and Pharmaceutical Sciences, Volume 6, Issue 5, 1017-1026.
36. N. Sunitha1*, Subash C Marihal 2, J. Sai Sravanthi 3, A.Venu 3, B.V.Narasimha Rao3 and B. Appa Rao3, Method Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Olmesartan and Cilnidipine in Bulk and Formulations, International Journal of Pharmaceutical Research & Allied Sciences, Volume 4, Issue 3 (2015):127-135.