Volume : 12, Issue : 10, October – 2025

Title:

RP-HPLC METHOD AND ITS VALIDATION FOR ANALYSIS OF CARBAMAZEPINE AND VALPROIC ACID IN BULK AND PHARMACEUTICAL DOSAGE FORM

Authors :

K. Mahesh*, Dr. Alivelu Samala, Dr. D. Venkata Ramana.

Abstract :

A simple, accurate, and reproducible Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Carbamazepine and Valproic Acid in bulk drugs and pharmaceutical dosage forms. The chromatographic separation was carried out using a Waters HPLC system equipped with an auto sampler and PDA detector (996 model). An Altima C18 column (4.6 × 150 mm, 5 µm) was used with a mobile phase consisting of Methanol and Acetonitrile (50:50 v/v) at a flow rate of 1.0 mL/min. Detection was performed at a wavelength of 230 nm, with a column temperature maintained at 35°C and an injection volume of 10 µL. The total run time was 10 minutes. The method was validated as per ICH Q2(R1) guidelines, and results confirmed excellent linearity, accuracy, precision, specificity, and robustness for both drugs. The proposed method is highly suitable for the routine quality control of Carbamazepine and Valproic Acid in pharmaceutical formulations, offering advantages of short analysis time, cost-effectiveness, and high sensitivity.
Keywords: RP-HPLC, Carbamazepine and Valproic Acid, ICH guidelines, Altima C18 column, Simultaneous estimation, Validation.

Cite This Article:

Please cite this article in press K. Mahesh et al., Rp-Hplc Method And Its Validation For Analysis Of Carbamazepine And Valproic Acid In Bulk And Pharmaceutical Dosage Form , Indo Am. J. P. Sci, 2025; 12(10).

REFERENCES:

1. V. Gupta, A.D. K. Jain, N.S. Gill, K. Gupta, Development and validation of HPLC method – a review, Int. Res J Pharm. App Sci., 2(4) (2012) 17-25
2. Y. Kazakevich, R. Lobrutto, HPLC for Pharmaceutical Scientists, John Wiley & Sons, New Jersey, 2007.
3. S. Ahuja, H. Rasmussen, Development for Pharmaceuticals, Vol.8 Separation Science and Technology, Elsevier, New York 2007.
4. M.S. Azim, M. Mitra, P.S. Bhasin, HPLC method development and validation: A review, Int. Res. J. Pharm. 4(4) (2013) 39-46.
5. B.V. Rao, G.N. Sowjanya1, A. Ajitha, V.U.M. Rao, Review on stability indicating hplc method development, World Journal of Pharmacy and Pharmaceutical Sciences, 4(8) (2015) 405-423.
6. M.S. Charde, A.S. Welankiwar, J. Kumar, Method development by liquid chromatography with validation, International Journal of Pharmaceutical Chemistry, 04 (02)(2014) 57-61.
7. S. Sood, R. Bala, N.S. Gill, Method development and validation using HPLC technique – A review, Journal of Drug Discovery and Therapeutics 2 (22) 2014, 18- 24.
8. M.W. Dong, Modern Hplc for practicing scientists, John Wiley & Sons, New Jersey, 2006.
9. P.K. Singh, M. Pande, L.K. Singh, R.B. Tripathi, steps to be considered during method development and validation for analysis of residual solvents by gas chromatography, Int. Res J Pharm. App Sci., 3(5) (2013) 74-80.
10. B. Prathap, G.H.S. Rao, G. Devdass, A. Dey, N. Harikrishnan, Review on Stability Indicating HPLC Method Development, International Journal of Innovative Pharmaceutical Research.3(3) (2012) 229- 237.
11. B. Sriguru, N.P. Nandha, A.S. Vairale, A.V. Sherikar, V. Nalamothu, Development and validation of stability indicating HPLC method for the estimation of 5- Fluorouracil and related substances in topical formulation, Int. J. Res. Pharm. Sci. 1 (2) (2010) 78- 85.
12. C.K. Kaushal, B. Srivastava, A process of method development: A chromatographic approach, J. Chem. Pharm. Res. 2(2) (2010) 519-545.
13. N. Toomula, A. Kumar, S.D. Kumar, V.S. Bheemidi, Development and Validation of Analytical Methods for Pharmaceuticals, J Anal Bioanal Techniques. 2(5) (2011) 1-4.
14. K. Kardani, N. Gurav, B. Solanki, P. Patel, B. Patel, RP-HPLC Method Development and Validation of Gallic acid in Polyherbal Tablet Formulation, Journal of Applied Pharmaceutical Science. 3 (5) (2013) 37- 42.
15. B. Nigovic, A. Mornar, M. Sertic, Chromatography – The Most Versatile Method of Chemical Analysis, Intech (2012) 385-425.
16. T. Bhagyasree, N. Injeti, A. Azhakesan, U.M.V. Rao, A review on analytical method development and validation, International Journal of Pharmaceutical Research & Analysis, Vol 4 (8) (2014) 444-448.
17. A. Shrivastava, V.B. Gupta, HPLC: Isocratic or Gradient Elution and Assessment of Linearity in Analytical Methods, J Adv Scient Res, 3(2) (212) 12- 20.
18. V. Kumar, R. Bharadwaj, G.G., S. Kumar, An Overview on HPLC Method Development, Optimization and Validation process for drug analysis, The Pharmaceutical and Chemical Journal, 2(2) (2015) 30-40.
19. Validation of Analytical Procedures: Text and Methodology, International Conferences on Harmonization, Draft Revised (2005), Q2 (R1).
20. Validation of Compendial Procedures, United State Pharmacopeia, USP 36 NF, 27 (2) (2010).
21. Mohammad Ehsan Mohammadi-Arani, Ramin Zibaseresht , Mohsen Chamanara , Reza Mosaed , Mohammad Mahboubi-Rabbani , Maryam Bayanati , Hossein Fasihi. A Review of HPLC Methods Developed for Quantitative Analysis of Carbamazepine in Plasma Samples, J. Chem. Rev., 2024, 6(1), 76-93.
22. Said A. Hassan, Helmy, A.H., Weshahy, S.A. et al. Development and Bioanalytical Validation of RP-HPLC Method for the Simultaneous Determination of Perampanel and Carbamazepine in Human Plasma for Therapeutic Drug Monitoring. J Anal Chem 78, 622–627 (2023).
23. ASTRI Budikayantia, B, CHISWYTA Chalianac, MELVA Louisac, RIANTO Setiabudyc. Development and Validation of Carbamazepine Plasma Concentrations Measurement And Its Application on Epilepsy Patients. International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 9, Issue 9, 2017.
24. Fortuna, A., Sousa, J., Alves, G. et al. Development and validation of an HPLC-UV method for the simultaneous quantification of carbamazepine, oxcarbazepine, eslicarbazepine acetate and their main metabolites in human plasma. Anal Bioanal Chem 397, 1605–1615 (2010).
25. Demirkaya, Fatma; Kadioglu, Yücel.  Determination of Carbamazepine Using RP-HPLC Method in Pharmaceutical Preparations. FABAD Journal of Pharmaceutical Sciences; Ankara Vol. 30, Iss. 2, (Jun 2005): 78-82.