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Sci. Pharm. 2012, 80(2), 407-418; doi:10.3797/scipharm.1112-07

Stability-Indicating Liquid Chromatographic Method for the Quantification of the New Antipsychotic Agent Asenapine in Bulk and in Pharmaceutical Formulation

1
Indukaka Ipcowala College of Pharmacy, Beyond GIDC Phase V, Vithal Udyognagar, New Vallabh Vidyanagar-388121, Anand, Gujarat, India
2
Sun Pharmaceutical Industries Ltd, Baroda, Gujarat, India
*
Author to whom correspondence should be addressed.
Received: 10 December 2011 / Accepted: 1 April 2012 / Published: 1 April 2012
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Abstract

A simple, specific and stability-indicating reversed phase high performance liquid chromatographic method was developed for the quantitative determination of asenapine in tablet dosage form. A SunFire C18, 5 μm column having 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.02 M potassium dihydrogen phosphate: acetonitrile (95:05, v/v, pH 3.5 adjusted with 1% o-phosphoric acid) was used. The flow rate was 1.0 mL min−1 and effluents were monitored at 232 nm. The retention time of asenapine was 5.51 min. The linearity for asenapine was in the range of 0.1–20 μg/ml. The recoveries obtained for asenapine were 98.31–101.51%. Asenapine stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation, sunlight and dry heat degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed LC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of asenapine in tablet dosage form.
Keywords: Asenapine; Reversed phase liquid chromatography; RP-HPLC; Forced degradation; Validation; Saphris; Sycrest Asenapine; Reversed phase liquid chromatography; RP-HPLC; Forced degradation; Validation; Saphris; Sycrest
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

CHHALOTIYA, U.K.; BHATT, K.K.; SHAH, D.A.; PATEL, J.R. Stability-Indicating Liquid Chromatographic Method for the Quantification of the New Antipsychotic Agent Asenapine in Bulk and in Pharmaceutical Formulation. Sci. Pharm. 2012, 80, 407-418.

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