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Quantitative determination of insulin entrapment efficiency in triblock copolymeric nanoparticles by high-performance liquid chromatography.
J Pharm Biomed Anal. 2006 Apr 11; 41(1):266-73.JP

Abstract

A rapid and effective isocratic chromatographic procedure was described in this paper for the determination of insulin entrapment efficiency (EE) in triblock copolymeric nanoparticles using reversed-phase high-performance liquid chromatography (RP-HPLC) with an ultraviolet/visible detector at low flow rate. The method has been developed on a Shimadzu Shim-pack VP-ODS column (150 mm x 4.6 mm, 5 microm, Chiyoda-Ku, Tokyo, Japan) using a mixture of 0.2 M sodium sulfate anhydrous solution adjusted to pH 2.3 with phosphoric acid and acetonitrile (73:27, v/v) as mobile phase at the flow rate of 0.8 ml min(-1) and a 214 nm detection. The method was validated in terms of selectivity, linearity, precision, accuracy, solution stability, limit of detection (LOD) and limit of quantification (LOQ). The calibration curve was linear in the concentration range of 2.0-500.0 microg ml(-1), and the limits of detection and quantitation were 8 and 20 ng, respectively. The mean recovery of insulin from spiked samples, in a concentration range of 8-100 microg ml(-1), was 98.96% (R.S.D.= 2.51%, n = 9). The intra- and inter-assay coefficients of variation were less than 2.24%. The proposed method has the advantages of simple pretreatment, rapid isolation, high specificity and precision, which can be used for direct analysis of insulin in commercially available raw materials, formulations of nanoparticles, and drug release as well as stability studies.

Authors+Show Affiliations

Xu X
West China School of Pharmacy, Sichuan University, No. 17, Section 3, Renmin Nan Road, Chengdu, Sichuan 610041, PR China.
Fu Y
No affiliation info available
Hu H
No affiliation info available
Duan Y
No affiliation info available
Zhang Z
No affiliation info available

MeSH

AcetonitrilesCalibrationChemistry, PharmaceuticalChromatographyChromatography, High Pressure LiquidHumansHydrogen-Ion ConcentrationInsulinNanostructuresPhosphoric AcidsPolymersReproducibility of ResultsTechnology, PharmaceuticalTime Factors

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16303273

Citation

Xu, Xiongliang, et al. "Quantitative Determination of Insulin Entrapment Efficiency in Triblock Copolymeric Nanoparticles By High-performance Liquid Chromatography." Journal of Pharmaceutical and Biomedical Analysis, vol. 41, no. 1, 2006, pp. 266-73.
Xu X, Fu Y, Hu H, et al. Quantitative determination of insulin entrapment efficiency in triblock copolymeric nanoparticles by high-performance liquid chromatography. J Pharm Biomed Anal. 2006;41(1):266-73.
Xu, X., Fu, Y., Hu, H., Duan, Y., & Zhang, Z. (2006). Quantitative determination of insulin entrapment efficiency in triblock copolymeric nanoparticles by high-performance liquid chromatography. Journal of Pharmaceutical and Biomedical Analysis, 41(1), 266-73.
Xu X, et al. Quantitative Determination of Insulin Entrapment Efficiency in Triblock Copolymeric Nanoparticles By High-performance Liquid Chromatography. J Pharm Biomed Anal. 2006 Apr 11;41(1):266-73. PubMed PMID: 16303273.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quantitative determination of insulin entrapment efficiency in triblock copolymeric nanoparticles by high-performance liquid chromatography. AU - Xu,Xiongliang, AU - Fu,Yao, AU - Hu,Haiyan, AU - Duan,Yourong, AU - Zhang,Zhirong, Y1 - 2005/11/21/ PY - 2005/09/02/received PY - 2005/10/11/revised PY - 2005/10/15/accepted PY - 2005/11/24/pubmed PY - 2006/8/17/medline PY - 2005/11/24/entrez SP - 266 EP - 73 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 41 IS - 1 N2 - A rapid and effective isocratic chromatographic procedure was described in this paper for the determination of insulin entrapment efficiency (EE) in triblock copolymeric nanoparticles using reversed-phase high-performance liquid chromatography (RP-HPLC) with an ultraviolet/visible detector at low flow rate. The method has been developed on a Shimadzu Shim-pack VP-ODS column (150 mm x 4.6 mm, 5 microm, Chiyoda-Ku, Tokyo, Japan) using a mixture of 0.2 M sodium sulfate anhydrous solution adjusted to pH 2.3 with phosphoric acid and acetonitrile (73:27, v/v) as mobile phase at the flow rate of 0.8 ml min(-1) and a 214 nm detection. The method was validated in terms of selectivity, linearity, precision, accuracy, solution stability, limit of detection (LOD) and limit of quantification (LOQ). The calibration curve was linear in the concentration range of 2.0-500.0 microg ml(-1), and the limits of detection and quantitation were 8 and 20 ng, respectively. The mean recovery of insulin from spiked samples, in a concentration range of 8-100 microg ml(-1), was 98.96% (R.S.D.= 2.51%, n = 9). The intra- and inter-assay coefficients of variation were less than 2.24%. The proposed method has the advantages of simple pretreatment, rapid isolation, high specificity and precision, which can be used for direct analysis of insulin in commercially available raw materials, formulations of nanoparticles, and drug release as well as stability studies. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/16303273/Quantitative_determination_of_insulin_entrapment_efficiency_in_triblock_copolymeric_nanoparticles_by_high_performance_liquid_chromatography_ DB - PRIME DP - Unbound Medicine ER -