Paper Titles in Periodical
International Letters of Chemistry, Physics and Astronomy
Volume 56

Subscribe

Subscribe to our Newsletter and get informed about new publication regulary and special discounts for subscribers!

ILCPA > Volume 56 > Development and Validation of UV...
< Back to Volume

Development and Validation of UV Spectrophotometric Method for Estimation of Agomelatine in Bulk and Pharmaceutical Dosage Form

Full Text PDF

Abstract:

A simple, rapid, accurate, precise, sensitive and economical UV Spectrophotometric method has been developed for estimation of agomelatine from bulk and pharmaceutical formulation. The λmax of agomelatine in water was found to be 233 nm. The parameters linearity, precision, accuracy, robustness were studied according to International Conference on Harmonization guidelines. The drug follows linearity in the concentration range 2-8μg/ml with correlation coefficient value 0.9981. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 50%, 100% and 150 %. The % recovery was found to be in the range 98.94%– 100.05%. The low values of % R.S.D. are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % R.S.D. value less than 2 indicate that the method is precise. The above method was a cost-effective quality-control tool for routine analysis of agomelatine in bulk and in pharmaceutical dosage form.

Info:

Periodical:
International Letters of Chemistry, Physics and Astronomy (Volume 56)
Pages:
113-119
DOI:
https://doi.org/10.18052/www.scipress.com/ILCPA.56.113
Citation:
R. H. Rupareliya and H. S. Joshi, "Development and Validation of UV Spectrophotometric Method for Estimation of Agomelatine in Bulk and Pharmaceutical Dosage Form", International Letters of Chemistry, Physics and Astronomy, Vol. 56, pp. 113-119, 2015
Online since:
Jul 2015
Authors:
Reema H. Rupareliya, Hitendra S. Joshi
Keywords:
Agomelatine, UV Spectrophotometric Method, Validation
Export:
RIS, BibTeX, Text
Distribution:
Open Access

Creative Commons License
This work is licensed under a
Creative Commons Attribution 4.0 International License

References:

[1] Singh SP, Singh, V, Kar N. Efficacy of agomelatine in major depressive disorder meta-analysis and appraisal. International Journal of Neuropsychopharmacology, 2012; 15: 417-428.

DOI: https://doi.org/10.1017/s1461145711001301

[2] Girish, MB, Bhuvana K, Nagesh RG, Sarala, N. A novel atypical antidepressant drug: Agomelatine – A review. International Journal of Pharmaceutical and Biomedical Research, 2010; 1(3): 113-116.

[3] Girstaute D, Paul L, Tim J, Cecilia G, Elisabeth M, Johan D. Chronic Stress and Antidepressant Agomelatine Induce Region-Specific Changes in Synapsin I Expression in the Rat Brain. Journal of Neuroscience Research, 2011; 89: 1646-1657.

DOI: https://doi.org/10.1002/jnr.22697

[4] Patil SR, Nerukar KK, Kalamkar AM, Pukale V, Mangaonkar KV, Pingale SG. Validated LC-MS/MS method for quantification of agomelatine in human plasma and its application in a pharmaceutical study. Journal of Mass Spectrometry, 2012; 47: 23-28.

DOI: https://doi.org/10.1002/jms.2020

[5] Rao VP, Prabhakar T, Naveen RC, Ramakrishna S, Trinath G. Clinical and pharmacological review on novel melatonergic antidepressant: Agomelatine. Research Journal of Pharmaceutical, Biological and Chemical Sciences, 2010; 1(2): 446-450.

[6] Singh, S., Bakshi, M. Guidance on conduct of stress tests to determine inherent stability of drugs. Pharmaceutical Technology On-line, 2000; 24: 1-14.

[7] Ram VR, Dave PN, Joshi HS. Development and validation of a stability indicating HPLC assay method for simultaneously determination of Spironolactone and Furosemide in tablet formulation. Journal of chromatographic science, 2012; 00: 1-6.

DOI: https://doi.org/10.1093/chromsci/bms062

[8] Saranjit S, Baljinder S, Rakesh B, Lalit W, Rahul S. Stress degradation studies on ezetimibe and development of a validated stability-indicating HPLC assay. Journal of Pharmaceutical and Biomedical Analysi, 2006; 41: 1037-1040.

DOI: https://doi.org/10.1016/j.jpba.2006.01.030

[9] YaravedaLathareddy, Naidu SrinivasaRao. Stability-Indicating RP-HPLC Method and Its Validation for Analysis of Metformin &Sitagliptin in Bulk and Pharmaceutical Dosage Form, World Journal of Pharmacy and Pharmaceutical Sciences, 2013; 2(5): 3691-3709.

DOI: https://doi.org/10.20959/wjpps20178-9786

[10] Monika B, Saranjit S. Development of validated stability-indicating assay methodscritical review. Journal of Pharmaceutical and Biomedical Analysis, 2002; 28: 10111040.

DOI: https://doi.org/10.1016/s0731-7085(02)00047-x

[11] Xue-jun H, Ren Z, Wang J, Liu J, Du Y, Quio H. Determenation of Agomelatine by RP-HPLC. HuaxiYaoxueZazhi, 2010; 25(2): 204-205.

[12] Ning M. HPLC method for separating and analyzing agomelatine intermediate and final product thereof. Faming ZhuanliShenquingGongkaiShuomingshu, 2008; CN 101206200 A 20080625.

[13] Kher GJ, Ram VR, Dubal KD, Bapodra AH, Joshi HS. Validation of a StabilityIndicating LC Method for Assay of Lefunomide in Tablets and for Determination of Content Uniformity. International Journal of ChemTech Research, 2011: 3(2): 523530.

Show More Hide