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Volume 80
Issue 2
10.3797/scipharm.1112-07
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Article

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

by
Usmangani K. CHHALOTIYA
1,*,
Kashyap K. BHATT
1,
Dimal A. SHAH
1 and
Jigar R. PATEL
2
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.
Sci. Pharm. 2012, 80(2), 407-418; https://doi.org/10.3797/scipharm.1112-07
Submission received: 10 December 2011 / Accepted: 1 April 2012 / Published: 1 April 2012
Versions Notes

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

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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. https://doi.org/10.3797/scipharm.1112-07

AMA Style

CHHALOTIYA UK, BHATT KK, SHAH DA, PATEL JR. Stability-Indicating Liquid Chromatographic Method for the Quantification of the New Antipsychotic Agent Asenapine in Bulk and in Pharmaceutical Formulation. Scientia Pharmaceutica. 2012; 80(2):407-418. https://doi.org/10.3797/scipharm.1112-07

Chicago/Turabian Style

CHHALOTIYA, Usmangani K., Kashyap K. BHATT, Dimal A. SHAH, and Jigar R. PATEL. 2012. "Stability-Indicating Liquid Chromatographic Method for the Quantification of the New Antipsychotic Agent Asenapine in Bulk and in Pharmaceutical Formulation" Scientia Pharmaceutica 80, no. 2: 407-418. https://doi.org/10.3797/scipharm.1112-07

APA Style

CHHALOTIYA, U. K., BHATT, K. K., SHAH, D. A., & PATEL, J. R. (2012). Stability-Indicating Liquid Chromatographic Method for the Quantification of the New Antipsychotic Agent Asenapine in Bulk and in Pharmaceutical Formulation. Scientia Pharmaceutica, 80(2), 407-418. https://doi.org/10.3797/scipharm.1112-07

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