Author(s):
Srinivasa Rao Narala, K. Saraswathi
Email(s):
srinunarala@gmail.com
DOI:
10.52711/0974-360X.2026.00494 
Address:
Srinivasa Rao Narala1*, K. Saraswathi2
1Department of Chemistry, R.V.R. & J.C. College of Engineering, Guntur, A.P., India.
2Department of Chemistry, S.V. University, Tirupathi, A.P., India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 8,
Year - 2026
ABSTRACT:
Validated methods for the determination of Manidipine dihydrochloride have been developed by using reverse phase high performance liquid chromatography and visible spectrophotometry in bulk drug. Chromatographic separation was carried out using a mobile phase of acetonitrile, methanol and tetrahydrofuran in proportion of 90:05:05 (v/v) on kromosil C18 column (250 X 4.6mm, 5µm) in an isocratic mode at a flow rate of 1.0ml/min. with detection at 239nm using a UV detector. The linearity was obtained in the concentration range of 30 –70 µg/ml. Spectrophotometric determination was carried out at an absorption maximum of 410nm using Vanillin. The Beer’ law is obeyed in the concentration range of 10-60µg/ml. The developed methods were found to be precise, accurate and also suitable for the determination of Manidipine dihydrochloride in pharmaceutical dosage forms.
Cite this article:
Srinivasa Rao Narala, K. Saraswathi. Validation of HPLC and Visible Spectrophotometric Methods for the Determination of Manidipine in Bulk drug. Research Journal of Pharmacy and Technology. 2026;19(8):3489-1. doi: 10.52711/0974-360X.2026.00494
Cite(Electronic):
Srinivasa Rao Narala, K. Saraswathi. Validation of HPLC and Visible Spectrophotometric Methods for the Determination of Manidipine in Bulk drug. Research Journal of Pharmacy and Technology. 2026;19(8):3489-1. doi: 10.52711/0974-360X.2026.00494 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-8-11
REFERENCES:
1. Yamashita M, Yamashita K, Aoki I, Tabata T, Hirai SI, Yashiki T. Journal of Chromatography B. 1992; 575(1): 123-129.
2. Ohkubo T, Uno T, Sugawara K. Liquid chromatographic determination of Manidipine in serum with electrochemical detection. Journal of ; Chromatogr B. 1996687: 413-418.
3. Rudzki PJ, Katarzyna B, Ksycinska H, Kobylinska K. J. Pharm. Biomed. Anal. 2007; 44(2): 356-367.
4. Todeschini V, da Silva Sangoi M, Volpato NM, Delapril. Manidipine measurements by liquid chromatography—tandem mass spectrometry in a pharmaceutical formulation. European Journal of Mass Spectrometry. 2011; 17(3).
5. Huong Lan Nguyen, et al. Determination of Manidipine in Human Plasma by UPLC–MS/MS and its Application to a Bioequivalence Study. Current Pharmaceutical Analysis. 2016; 12(2): 152-156.
6. Wannisa Thanakosai, et al. Development and validation of liquid chromatography tandem mass spectrometry method for the quantification of Manidipine in human plasma. Pharm Sci Asia. 2020; 47 (2): 142-152.
7. Jing J, Ren W, Chen X, He H et al. Determination and pharmacokinetics of Manidipine in human plasma by HPLC/ ESIMS Biomed Chromatogr. 2007; 21: 836-840.
8. Mahaveer S, Kashkhedikar SG, Soni L, Abhinav G, Gandhi T, Amrish P. Development of RP-HPLC Method for Estimation of Carvedilol in Tablet Formulations. Research J. Pharm. and Tech. 2008; 1(1): 18-22.
9. Kiran Kumar V, Appala Raju N, Shabana B, Seshagiri Rao JVLN, Satyanarayana T. The Estimation of Aprepitant in Capsules Dosage forms by RP-HPLC. Research J. Pharm. and Tech. 2009; 2(2): 412-414.
10. Panditi VR, Gnana Babu CJ, Channa Basavaraj KP, Sharada CH, Bhargava Reddy Y. Validated RP- HPLC Method for the Quantitation of Stavudine in Bulk and Pharmaceutical Dosage Forms. Research J. Pharm. and Tech. 2010; 3(3): 770-772.
11. Santhosh Kumar MS, Channa Basavara KP, Gnana Babu JC, Tamizh Mani T. Validated RP- HPLC Method for the Quantitation of Nebivolol in Bulk and Pharmaceutical Dosage Forms. Research J. Pharm. and Tech. 2010; 3(4): 1167-1169.
12. Venkatesh V, Elphine Prabahar A, Venkata Suresh P, Umamaheswari CH, Rama Rao N. A New RP-HPLC Method for Simultaneous Estimation of Etophylline and Theophylline in Tablets. Research J. Pharm. and Tech. 2011; 4(1): 128-130.
13. Chansapha Pamanivong, Walapa Tatong. Determination of Manidipine hydrochloride in tablets by HPLC. Journal of Health Research. 2012; 26(1).
14. Bhavik SP, Chetan AP. Development and validation of stability indicating RP-HPLC method for estimation of Manidipine hydrochloride in pharmaceutical dosage form. PharmaTutor. 2014; 2(11).
15. Srinivasa Rao N, Saraswathi K. High Performance Liquid Chromatographic Method for the Determination of Mesalamine in Bulk Drug and Pharmaceutical Dosage Forms. Research J. Pharm. and Tech. 2022; 15(1): 301-304.20.
16. De Laurentis N, Losacco V, Milillo MA, Zarrilli A. Boll Chim Farm. 2001; 140(1): 15-19.
17. Ragno G, Aiello F, Garofalo A, Ioele G, Sinicropi MS. Multivariate least squares regression applied to the spectrophotometric analysis of Manidipine and its main photoproduct. Farmaco. 2003; 58: 909-915.
18. Polawar PV, Shivhare UD, Bhusari KP, MathurVB. Development and Validation of Spectrophotometric Method of Analysis for Fexofenadine HCl. Research J. Pharm. and Tech. 2008; 1(4): 539-541.
19. Lakshmi S, Manikandan K, Venkatesan M, Lakshmi KS. Pharmaceutical Analysis. 2009; 1 (1): 175-179.
20. Karthikeyan R, Thangabalan B, Elphine Prabahar A, Vijayaraj Kumar P. New Spectrophotometric Methods for the Determination of Imatinib in Bulk Drug and in Pharmaceutical Formulations. Research J. Pharm. and Tech. 2009; 2(3): 578-581.
21. Srinivasa Rao N, Saraswathi K. Adaptation of Color Reactions for Spectrophotometric Determination of Mosapride Citrate in Formulations. Asian J. Research Chem. 2011; 4(6): 896-897.
22. Janaki Pathi P, Raveendra Reddy P, Appala Raju N. Visible Spectrophotometric Estimation of Atazanavir in Pharmaceutical Formulations. Research J. Pharm. and Tech. 2011; 4(2): 273-275.
23. Srinivasa Rao N, Saraswathi K. Application of Oxidants to the Spectrophotometric Determination of Cephalosporins (Cefditoren Pivoxil and Cefdinir) In Formulations. Asian J. Research Chem. 2011; 4(2): 270-271.
24. Srinivasa Rao N, Saraswathi K. Extractive Spectrophotometric Determination of Meropenem in Pharmaceutical Formulations. Research J. Pharm. and Tech. 2023; 16(9): 4148-4150.
25. Tojo, Akihiro, Kimura, Kenjiro, Matsuoka, Hiroaki, Sugimoto, Tsuneaki, J. Cardiovascular Pharmacology. 1992; 20(6): 895-899.
26. Y Tokuma, H Noguchi. Stereoselective pharmacokinetics of dihydropyridine calcium Antagonists. J Chromatogr A. 1995; 694: 181-193.
27. Cataldi M, Taglialatela M, Palagiano F, Secondo A, Decaprariis P, Amoroso S, Di Renzo G, Annunziato L. European Journal of Pharmacology. 1999; 376(1-2): 169-178.
28. Stockis A, de Bruyn S, Gengler C, Goethals F, Lens S, Poli G, Acerbi D. Arzneimittelforschung. 2003; 53(8): 554-561.
29. Otero ML. Manidipine-delapril combination in the management of hypertension. Vasc Health Risk Manage. 2007; 3: 255-263.
30. Todeschini V et al. Delapril and Manidipine characterization and purity evaluation in raw materials. J Therm Anal Calorim. 2013; 115: 2295-2301.
31. Hassan AM, Hendawy et al. Nano-iron oxide supported on the printed electrode for voltammetric determination of Manidipine on a very small sample in different media, analytical and clinical Purposes. J. Electrochem. Soc. 2021; 168(12).
32. Kohei Kawabata et al. Photostability evaluation Manidipine tablets and structural determination of its photoproducts. Anal. Sci. 2024; 40(9): 1733-1747.