OPEN ACCESS | PEER-REVIEWED | SHORT COMMUNICATION | DOWNLOAD PDF | VIEW FULL-TEXT PDF | TOTAL VIEWS
Stability indicating HPTLC method for quantitative estimation of manidipine sihydrochloride API
Santhana Lakshmi Karunanidhi (1) , Lakshmi Sivasubramanian (2,*) , Manikandan Krishnan (3)
(1) Department of Pharmaceutical Analysis, Sri Ramasamy Memorial College of Pharmacy, Sri Ramasamy Memorial University, Kattankulathur, Tamilnadu, IN-603203, India
(2) Department of Pharmaceutical Analysis, Sri Ramasamy Memorial College of Pharmacy, Sri Ramasamy Memorial University, Kattankulathur, Tamilnadu, IN-603203, India
(3) Department of Pharmaceutical Analysis, Sri Ramasamy Memorial College of Pharmacy, Sri Ramasamy Memorial University, Kattankulathur, Tamilnadu, IN-603203, India
(*) Corresponding Author
Received: 01 May 2010 | Revised: 10 Aug 2010 | Accepted: 20 Sep 2010 | Published: 28 Mar 2011 | Issue Date: March 2011
A simple, selective, precise and stability indicating high performance thin layer chromatographic method has been established and validated for analysis of manidipine hydrochloride in bulk. The compound was analyzed on aluminium backed silica gel 60 F254 plates with methanol:water, 8.5:1.5 (v:v) as mobile phase. The system was found to give compact spots for manidipine dihydrochloride (RF=0.75). Densitometric analysis was performed at 230 nm. Regression analysis data for the calibration plot indicated good linear relationships between response and concentration over the range of 500-3000 ng/spot. The correlation coefficient, r2 was 0.998. The values of slope and intercept of the calibration plot were 2785.5 and 62.314, respectively. The method was validated for precision, recovery and robustness. The limits of detection and quantification were 20 and 50 ng, respectively. Manidipine dihydrochloride was subjected to acid, base, peroxide and sunlight induced degradation. In stability test the drug was susceptible to acid and base hydrolysis, oxidation and photodegradation. Statistical analysis proved that the method is repeatable, selective and accurate for manidipine. Because the method could effectively separate the drug from their degradation products, it can be used as a stability indicating method.
Links for Article
| | | | | | |
| | | | | | |
| | |
Article MetricsThis Abstract was viewed 842 times | PDF Article downloaded 308 times
Sri Ramasamy Memorial University
. Budavaris, Eds., The Merck Index, 13th Edition, Merck & Co., Inc., Whitehouse Station, NJ, 2001.
. Lakshmi, S.; Manikandan, K.; Venkatesan, M.; Lakshmi, K. S. J. Young. Pharmacist 2009, 1(2), 175-179.
. Jing, J.; Ren, W.; Chen, X.; He, H.; Zhou, W.; Zhu, X.; Sun, Y.; Wang, G. Biomed. Chromatogr. 2007, 21(8), 836-840.
. Ohkubo, T.; Uno, T.; Sugawara, K. J. Chromatogr. B Biomed. Appl. 1996, 687(2), 413-418.
. Miyabayashi, T.; Yamashita, K.; Aoki, I.; Motohashi, M.; Yashiki, T.; Yatani, K. J. Chromatogr. 1989, 494, 209-217.
. ICH, “Stability Testing of New Drug Substances and Procedure”, Proceeding of the International Conference on Harmonization, Geneva, 1993.
. Bakshi, M.; Singh, S. J. Pharm. Biomed. Anal. 2002, 28(6), 1011-1040.
. Bartsch, H.; Eiper, A.; Frank, H. K. J. Pharm. Biomed. Anal. 1999, 20, 531-541.
. Kotiyan, P. N.; Vavia, P. R. J. Pharm. Biomed. Anal. 2000, 22, 667-671.
. Puthli, S. P.; Vavia, P. R. J. Pharm. Biomed. Anal. 2000, 22, 673-677.
. Vadera, N.; Subramanian, G.; Musmade, P. J. Pharm. Biomed. Anal. 2007, 43, 722-726.
How to cite
The other citation formats (EndNote | Reference Manager | ProCite | BibTeX | RefWorks) for this article can be found online at: How to cite item
DOI Link: https://doi.org/10.5155/eurjchem.2.1.113-116.87
| | | | | | | | |
| | | | | |
Save to Zotero Save to Mendeley
European Journal of Chemistry 2011, 2(1), 113-116 | doi: https://doi.org/10.5155/eurjchem.2.1.113-116.87 | Get rights and content
- There are currently no refbacks.
© Copyright 2010 - 2021 • Atlanta Publishing House LLC • All Right Reserved.
The opinions expressed in all articles published in European Journal of Chemistry are those of the specific author(s), and do not necessarily reflect the views of Atlanta Publishing House LLC, or European Journal of Chemistry, or any of its employees.
Copyright 2010-2021 Atlanta Publishing House LLC. All rights reserved. This site is owned and operated by Atlanta Publishing House LLC whose registered office is 2850 Smith Ridge Trce Peachtree Cor GA 30071-2636, USA. Registered in USA.