Method Development and Validation of RP-HPLC Method for Determination of New Antipsychotic Agent Asenapine Maleate in Bulk and Pharmaceutical Formulation
 
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Department of Pharm Analysis, Smt Sarojini Ramulamma College of Pharmacy, India
Publish date: 2017-10-05
 
Eurasian J Anal Chem 2014;9(2):58–65
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ABSTRACT:
A novel isocratic reverse phase liquid chromatography method for determination of Asenapine Maleate was developed and validated after optimization of various chromatographic conditions. A Hiber C18, 5 μm column having 250×4.6 mm i.d., with mobile phase containing 0.05 M potassium dihydrogen phosphate : acetonitrile (60:40, v/v, pH 2.7 adjusted with 1% o-phosphoric acid) was used. The flow rate was 1.0 mL min-1 and effluents were monitored at 270 nm. The retention time of asenapine was 4.2min. The linearity for Asenapine maleate was in the range of 0-150 μg mL-1with coefficient of correlation 0.999. The proposed method was validated with respect to linearity, accuracy, precision and robustness.
CORRESPONDING AUTHOR:
Naga Rajan Govindarajan   
Department of Pharm Analysis, Smt Sarojini Ramulamma College of Pharmacy, India
 
REFERENCES (9):
1. Available from Drugs.com/ monograph/asenapine maleate.html(accessed on 28/1/12 ).
2. Available from url http://www.rxlist.com/saphris-... (accessed on 28/1/12).
3. Saphris®. Asenapine sublingual tablets. Full prescribing information. Schering Corporation, a subsidiary of Merck & Co. Inc 2010. White house Station, NJO. http://www.spfiles.com/pisaphr... [accessed January 2011].
4. European Medicines Agency. Sycrest asenapine. 2010. http://www.ema.europa.eu/ema/i... 77/human_med_001379.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac0 58001d124&jsenabled=true [accessed 28 September 2010].
5. Boer T, Meulman E, Meijering H, Wieling J, Dogterom P, Lass H (2012). Quantification of asenapine and three metabolites in human plasma using liquid chromatography–tandem mass spectrometry with automated solid-phase extraction: application to a phase I clinical trial with asenapine in healthy male subjects. Biomedical chromatography 26(2): 156-165.
6. Halima OA, Aneesh TP, Ghosh R, Thomas NR (2012).Development and validation of UV spectrophotometric method for the estimation of asenapine maleate in bulk and pharmaceutical formulation. Der Pharma Chemica 4 (2):644-649.
7. Gandhimathi R, Vijayaraj S, Jyothirmaie MP (2012) U.V Method development and validation for estimation of asenapine maleate in bulk and tablet formulation. International Journal of Medicinal Chemistry And Analysis 2(2):85-90.
8. ICH (1996) Harmonized tripartite guideline: validation of analytical procedures: Methodology Q2B.
9. ICH (1996) Harmonized tripartite guideline: validation of analytical procedures.Q2A.
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