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Screening of nanoemulsion components for asenapine maleate using validated RP-HPLC method.
Ann Pharm Fr. 2020 May 06 [Online ahead of print]AP

Abstract

A novel, simple reversed-phase high-performance liquid chromatographic (RP-HPLC) analytical method was developed and validated for the quantitative determination of asenapine from various nanoemulsion components during pre-formulation screening. The developed method was validated according to ICH Q2 (R1) guidelines. The developed and validated method was precisely and accurately quantified asenapine in various oils, surfactants and co-surfactants. The separation of asenapine was carried out on Hypersil BDS C18, 250x4.6 mm, 5 μm particle size column using methanol: acetonitrile (90:10) as mobile phase with a flow rate of 1 mL.min-1. Measurement at 270 nm for the 5 to 50 μg.mL-1 the concentration of the analyte was found to be linear with the determination coefficient (r2) of 0.999 as calculated by the least square regression method. The validated method was sensitive with LOD of 10.0 ng.mL-1 and LOQ of 30.0 ng.mL-1. Further, the method was precise and accurate, where the intraday and interday precision values were ranged from 0.70-0.95 and 0.36-0.95, respectively with the corresponding accuracy were ranged from 98.80-100.63 and 98.36-100.63. This developed and validated RP-HPLC method for asenapine was applied in the quantitative determination and screening of various oils, surfactants, and co-surfactants during the development of the asenapine maleate nanoemulsion.

Authors+Show Affiliations

School of Pharmaceutical Sciences, Jaipur National University, India; Department of Pharmaceutics, STES's Sinhgad Institute of Pharmacy (Affiliated to Savitribai Phule Pune University), India.Department of Pharmaceutics, STES's Sinhgad Institute of Pharmacy (Affiliated to Savitribai Phule Pune University), India.School of Pharmaceutical Sciences, Jaipur National University, India. Electronic address: director_pharmacy@jnujaipur.ac.in.School of Pharmacy, Faculty of Health and Medical Science, Taylor's University, Malaysia. Electronic address: bapi.gorain@taylors.edu.my.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32387177

Citation

Kumbhar, Santosh Ashok, et al. "Screening of Nanoemulsion Components for Asenapine Maleate Using Validated RP-HPLC Method." Annales Pharmaceutiques Francaises, 2020.
Kumbhar SA, Kokare CR, Shrivastava B, et al. Screening of nanoemulsion components for asenapine maleate using validated RP-HPLC method. Ann Pharm Fr. 2020.
Kumbhar, S. A., Kokare, C. R., Shrivastava, B., & Gorain, B. (2020). Screening of nanoemulsion components for asenapine maleate using validated RP-HPLC method. Annales Pharmaceutiques Francaises. https://doi.org/10.1016/j.pharma.2020.04.005
Kumbhar SA, et al. Screening of Nanoemulsion Components for Asenapine Maleate Using Validated RP-HPLC Method. Ann Pharm Fr. 2020 May 6; PubMed PMID: 32387177.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Screening of nanoemulsion components for asenapine maleate using validated RP-HPLC method. AU - Kumbhar,Santosh Ashok, AU - Kokare,Chandrakant R, AU - Shrivastava,Birendra, AU - Gorain,Bapi, Y1 - 2020/05/06/ PY - 2020/02/11/received PY - 2020/04/26/revised PY - 2020/04/27/accepted PY - 2020/5/11/entrez PY - 2020/5/11/pubmed PY - 2020/5/11/medline KW - RP-HPLC KW - asenapine maleate KW - nanoemulsion KW - pre-formulation study KW - sensitive method KW - validation JF - Annales pharmaceutiques francaises JO - Ann Pharm Fr N2 - A novel, simple reversed-phase high-performance liquid chromatographic (RP-HPLC) analytical method was developed and validated for the quantitative determination of asenapine from various nanoemulsion components during pre-formulation screening. The developed method was validated according to ICH Q2 (R1) guidelines. The developed and validated method was precisely and accurately quantified asenapine in various oils, surfactants and co-surfactants. The separation of asenapine was carried out on Hypersil BDS C18, 250x4.6 mm, 5 μm particle size column using methanol: acetonitrile (90:10) as mobile phase with a flow rate of 1 mL.min-1. Measurement at 270 nm for the 5 to 50 μg.mL-1 the concentration of the analyte was found to be linear with the determination coefficient (r2) of 0.999 as calculated by the least square regression method. The validated method was sensitive with LOD of 10.0 ng.mL-1 and LOQ of 30.0 ng.mL-1. Further, the method was precise and accurate, where the intraday and interday precision values were ranged from 0.70-0.95 and 0.36-0.95, respectively with the corresponding accuracy were ranged from 98.80-100.63 and 98.36-100.63. This developed and validated RP-HPLC method for asenapine was applied in the quantitative determination and screening of various oils, surfactants, and co-surfactants during the development of the asenapine maleate nanoemulsion. SN - 0003-4509 UR - https://www.unboundmedicine.com/medline/citation/32387177/Screening_of_nanoemulsion_components_for_asenapine_maleate_using_validated_RP-HPLC_method L2 - https://linkinghub.elsevier.com/retrieve/pii/S0003-4509(20)30053-5 DB - PRIME DP - Unbound Medicine ER -
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