Volume : 13, Issue : 05, May – 2026
Title:
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF NIMODIPINE IN BULK AND MARKETED PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC
Authors :
Kuchuri Mounika*, Vijaya Kuchana, Pasupuleti Sunitha, G. Kalyani
Abstract :
Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredient and Marketed Pharmaceutical Dosage form of Nimodipine.
Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Nimodipine. The chromatographic strategy utilized Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5µm, using isocratic elution with a mobile phase of Phosphate Buffer (0.02M) and Acetonitrile were consists of 48:52% v/v (pH-2.80). A flow rate of 1.0 ml/min and a detector wavelength of 248 nm utilizing the UV detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines.
Results: LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range.
Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drug.
Key Words: Nimodipine, RP-HPLC, Method Development, Validation, Accuracy, Robustness.
Cite This Article:
Please cite this article in press Kuchuri Mounika et al., Analytical Method Development And Validation For The Quantitative Estimation Of Nimodipine In Bulk And Marketed Pharmaceutical Dosage Forms By Rp-Hplc.., Indo Am. J. P. Sci, 2026; 13(05).
REFERENCES:
1. https://go.drugbank.com/drugs/DB00393
2. https://en.wikipedia.org/wiki/Nimodipine
3. https://pubchem.ncbi.nlm.nih.gov/compound/000004497
4. Journal of Pharmaceutical and Biomedical Analysis Volume 21, Issue 2, Pages 371–382, 1 November 1999.
5. Tropical Journal of Pharmaceutical Research, © Pharmacotherapy Group, Volume: 8(5), Pg No: 449-454, October 2009.
6. Rabi Sankar, Instrumental Method of Analysis, P-18-6, P-18-3.
7. Lloyd R. Snyder et al, Practical HPLC Method Development, 2nd edition, P-503.
8. Guidance for industry, Analytical Procedure and Method Validation, U.S. Department of Health and Human Services FDA, August 2000.
9. Y. F. Cheng, T.H. Walter, Z. Lu, P. Iraneta, C. Gendreau, U. D. Neue, J. M. Grassi, J. L. Carmody, J. E. O’ Gara, and R. P. Fisk, LCGC, Volume: 18(10), 1162 , 2000.
10. The United State Pharmacopeia 25/National Formulary 20, Ch. 1225, (The United State Pharmacopeia Convention, Inc., Rockville, Maryland, pg. 2256-2259, 2002.
11. ICH Q2B: Validation of Analytical Procedure; Methodology (International Conferences on Harmonization of Technical requirements for the registration of Drugs for Human use, Geneva, Switzerland, May 1997.
12. ICH Q2B: Validation of Analytical Procedure; Methodology (International Conferences on Harmonization of Technical requirements for the registration of Drugs for Human use, Geneva, Switzerland, Nov 2003.
13. M. V. Gorenstein, J. B. Li, J. Van Antwerp, and D. Chapman, LCGC Volume 12(10), Pg no: 768-772 , 1994.
14. Matheson A.J., Noble S., Drugs, Volume 59, ISSN Number 4, Pg no: 829-835, 2000.
15. Anttila S, Leinonen E: Duloxetine Eli Lilly. Curr Opin Investig Drugs.; Volume: 3 (8), Pg no: 1217-21, 2002.
16. Gan TJ: Selective serotonin 5-HT3 receptor antagonists for postoperative nausea and vomiting: are they all the same? CNS Drugs.; Volume; 19 (3), Pg no: 225-38, 2005.
17. Tan M: Granisetron: new insights into its use for the treatment of chemotherapy-induced nausea and vomiting. Expert Opin Pharmacother. Volume: 4(9), Pg no: 1563-71, 2003.
18. Ahuja S. In: High Pressure Liquid Chromatography of Comprehensive Analytical Chemistry. Elsevier Publications. 2006.
19. Principles and Methods. In: Amesham Biosciences of Reversed Phase Chromatography. 6-8.
20. Synder LR, Kirkland JJ and Glajch JL. In: Practical HPLC Method Development, 2nd Ed, John Wiley and Sons Inc. Canada. 1997.
21. Mohammad T et al., HPLC Method Development and Validation for Pharmaceutical Analysis- A Review. International Pharmaceutica Sciencia. 2012, 2(3), 14.
22. Snyder LR, Kirkland JJ and Glajch JL. In: Practical HPLC Method Development. 2nd ed, 2001.
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. Lubna B. Shaikh*1, Vishal V. Pande2, Deepak S. Musmade3 and Poonam P. Patil3, Development and Validation of RP-HPLC Method for Estimation of Process Related Impurity in Nimodipine Bulk and Formulation, Scholars Research Library Der Pharmacia Lettre, 2015, 7 (3): 287-290.
32. Xiaojun Shang, Suying Ma, Zheshen Li, Development and Validation of a RP-HPLC Method for Determination of Nimodipine in Sustained Release Tablets, Journal of Chemistry, Volume 2013, Article ID 612082, 4 pages, http://dx.doi.org/10.1155/2013/612082.
33. Kasture V.S.*, Pawar S.S., Patil P.P., Musmade D.S., Ajage R. K. and Gehlot Ganjendra, Development and Validation of Rp-Hplc Method for the Estimation of Process Related Impurities from Nimodipine Bulk and Formulation, International Journal of Pharmacy, 2014; 4(2): 189-195.
34. B. Rajani* and K. Mukkanti, Optimized and Validated RP-HPLC Method for the Estimation of Nimodipine in Tablet Dosage Form, International Journal of Research In Pharmacy and Chemistry, IJRPC 2014, 4(1), 105-109.




