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Stability-indicating liquid chromatographic method for the quantification of the new antipsychotic agent asenapine in bulk and in pharmaceutical formulation.
Sci Pharm. 2012 Apr-Jun; 80(2):407-17.SP

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 C(18), 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.

Authors+Show Affiliations

Indukaka Ipcowala College of Pharmacy, Beyond GIDC Phase V, Vithal Udyognagar, New Vallabh Vidyanagar-388121, Anand, Gujarat, India.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22896826

Citation

Chhalotiya, Usmangani K., et al. "Stability-indicating Liquid Chromatographic Method for the Quantification of the New Antipsychotic Agent Asenapine in Bulk and in Pharmaceutical Formulation." Scientia Pharmaceutica, vol. 80, no. 2, 2012, pp. 407-17.
Chhalotiya UK, Bhatt KK, Shah DA, et al. Stability-indicating liquid chromatographic method for the quantification of the new antipsychotic agent asenapine in bulk and in pharmaceutical formulation. Sci Pharm. 2012;80(2):407-17.
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), 407-17. https://doi.org/10.3797/scipharm.1112-07
Chhalotiya UK, et al. Stability-indicating Liquid Chromatographic Method for the Quantification of the New Antipsychotic Agent Asenapine in Bulk and in Pharmaceutical Formulation. Sci Pharm. 2012 Apr-Jun;80(2):407-17. PubMed PMID: 22896826.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stability-indicating liquid chromatographic method for the quantification of the new antipsychotic agent asenapine in bulk and in pharmaceutical formulation. AU - Chhalotiya,Usmangani K, AU - Bhatt,Kashyap K, AU - Shah,Dimal A, AU - Patel,Jigar R, Y1 - 2012/04/01/ PY - 2011/12/10/received PY - 2012/04/01/accepted PY - 2012/8/17/entrez PY - 2012/8/17/pubmed PY - 2012/8/17/medline KW - Asenapine KW - Forced degradation KW - RP-HPLC KW - Reversed phase liquid chromatography KW - Saphris KW - Sycrest KW - Validation SP - 407 EP - 17 JF - Scientia pharmaceutica JO - Sci Pharm VL - 80 IS - 2 N2 - 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 C(18), 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. SN - 2218-0532 UR - https://www.unboundmedicine.com/medline/citation/22896826/Stability_indicating_liquid_chromatographic_method_for_the_quantification_of_the_new_antipsychotic_agent_asenapine_in_bulk_and_in_pharmaceutical_formulation_ L2 - http://www.mdpi.com/resolver?pii=scipharm-2012-80-407 DB - PRIME DP - Unbound Medicine ER -
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