메뉴 건너뛰기




Volumn 4, Issue 2, 2012, Pages 353-358

New validated RP-HPLC method for the estimation of Carvedilol in pharmaceutical formulation

Author keywords

Carvedilol; Precise; Recovery; RP HPLC; UV detection

Indexed keywords

ACETONITRILE; CARVEDILOL; METHANOL;

EID: 84860012532     PISSN: None     EISSN: 09751491     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (6)

References (31)
  • 2
    • 34347233485 scopus 로고    scopus 로고
    • Population pharmacokinetics of S (-)-Carvedilol in healthy volunteers after administration of the immediate-release (IR) and the new controlled-release (CR) dosage forms of the racemate
    • Othman AA, Tenero DM, Boyle DA, Eddington ND, Fossler MJ. Population pharmacokinetics of S (-)-Carvedilol in healthy volunteers after administration of the immediate-release (IR) and the new controlled-release (CR) dosage forms of the racemate. AAPSJ, 2007; 9 (2): E208-18.
    • (2007) AAPSJ , vol.9 , Issue.2
    • Othman, A.A.1    Tenero, D.M.2    Boyle, D.A.3    Eddington, N.D.4    Fossler, M.J.5
  • 5
    • 0032212995 scopus 로고    scopus 로고
    • Carvedilol: The new role of beta blockers in congestive heart failure
    • Vanderhoff BT, Ruppel HM, Amsterdam PB. Carvedilol: The new role of beta blockers in congestive heart failure. Am FAM Physician, 1998; 58(7):1627-34.
    • (1998) Am FAM Physician , vol.58 , Issue.7 , pp. 1627-1634
    • Vanderhoff, B.T.1    Ruppel, H.M.2    Amsterdam, P.B.3
  • 6
    • 84859958751 scopus 로고    scopus 로고
    • Analytical method development & validation of carvedilol by HPLC in bulk and dosage form
    • Suddhasattya D, Dhiraj Kumar SA, Sreenivas D, Sandeep AC. Analytical method development & validation of carvedilol by HPLC in bulk and dosage form. Journal of Pharmacy Research, 2010; 3(12): 3075-3077.
    • (2010) Journal of Pharmacy Research , vol.3 , Issue.12 , pp. 3075-3077
    • Suddhasattya, D.1    Dhiraj, K.S.A.2    Sreenivas, D.3    Sandeep, A.C.4
  • 7
    • 77950909460 scopus 로고    scopus 로고
    • Development of Carvedilol assay in tablet dosage form usingHPLC with fluorescence detection
    • Pattana S, Somsak K, Sakawrat T. Development of Carvedilol assay in tablet dosage form usingHPLC with fluorescence detection. Maejo Int J Sci Technol, 2010; 4(1): 8-19.
    • (2010) Maejo Int J Sci Technol , vol.4 , Issue.1 , pp. 8-19
    • Pattana, S.1    Somsak, K.2    Sakawrat, T.3
  • 8
    • 33947358164 scopus 로고    scopus 로고
    • RP-HPLC and HPTLC methods for the estimation of Carvedilol in bulk drug and pharmaceutical formulations
    • Patel LJ, Suhagia BN, Shah PB, Shah RR. RP-HPLC and HPTLC methods for the estimation of Carvedilol in bulk drug and pharmaceutical formulations. Ind J pharma sci, 2006; 68(6): 790-793.
    • (2006) Ind J Pharma Sci , vol.68 , Issue.6 , pp. 790-793
    • Patel, L.J.1    Suhagia, B.N.2    Shah, P.B.3    Shah, R.R.4
  • 9
    • 7444230364 scopus 로고    scopus 로고
    • Stereoselective analysis of Carvedilol in human plasma using HPLC/MS/MS after chiral derivatization
    • Eric Y, Sherry W, John K, Matthew JC. Stereoselective analysis of Carvedilol in human plasma using HPLC/MS/MS after chiral derivatization. J Pharm Biom Anal, 2004; 36(3- 15): 609-615.
    • (2004) J Pharm Biom Anal , vol.36 , Issue.3-15 , pp. 609-615
    • Eric, Y.1    Sherry, W.2    John, K.3    Matthew, J.C.4
  • 10
    • 49949095971 scopus 로고    scopus 로고
    • HPLC analysis, isolation and identification of a new degradation product in Carvedilol tablets
    • Galanopoulou O, Rozou S, Antoniadou-Vyza E. HPLC analysis, isolation and identification of a new degradation product in Carvedilol tablets. J Pharm Biom Anal, 2008; 48(1- 10): 70-77.
    • (2008) J Pharm Biom Anal , vol.48 , Issue.1-10 , pp. 70-77
    • Galanopoulou, O.1    Rozou, S.2    Antoniadou-Vyza, E.3
  • 11
    • 48449106180 scopus 로고    scopus 로고
    • Stereoselective analysis of Carvedilol in human plasma and urine using HPLC after chiral derivatization
    • Peccinini RG, Ximenes VF, Cesarino EJ, Lanchote VL. Stereoselective analysis of Carvedilol in human plasma and urine using HPLC after chiral derivatization. Biopharm Drug Dispos, 2008; 29(5): 280-8.
    • (2008) Biopharm Drug Dispos , vol.29 , Issue.5 , pp. 280-288
    • Peccinini, R.G.1    Ximenes, V.F.2    Cesarino, E.J.3    Lanchote, V.L.4
  • 14
    • 84859980122 scopus 로고    scopus 로고
    • Rapid and Sensitive Carvedilol Assay in Human Plasma Using a High-Performance Liquid Chromatography with Mass/Mass Spectrometer Detection Employed for a Bioequivalence Study
    • Soo-Hwan K, Sang Hun L, Hye Jung L. Rapid and Sensitive Carvedilol Assay in Human Plasma Using a High-Performance Liquid Chromatography with Mass/Mass Spectrometer Detection Employed for a Bioequivalence Study. Am J Analy Chem, 2010; 1: 135-14.
    • (2010) Am J Analy Chem , vol.1 , pp. 135-140
    • Soo-Hwan, K.1    Sang, H.L.2    Hye, J.L.3
  • 15
    • 34247344012 scopus 로고    scopus 로고
    • New RP-HPLC method with UVdetection for the determination of Carvedilol in human Serum
    • Gannu R, Yamsani VV, Rao YM. New RP-HPLC method with UVdetection for the determination of Carvedilol in human Serum. J Liq Chromatogr Relat Technol, 2007; 30(12): 1677-1685.
    • (2007) J Liq Chromatogr Relat Technol , vol.30 , Issue.12 , pp. 1677-1685
    • Gannu, R.1    Yamsani, V.V.2    Rao, Y.M.3
  • 16
    • 0003228192 scopus 로고
    • International Conference on Harmonization
    • Q2A: Text on Validation of Analytical Procedures
    • Q2A: Text on Validation of Analytical Procedures. In International Conference on Harmonization, Federal Register 1995; 60(40): 11260-11262.
    • (1995) Federal Register , vol.60 , Issue.40 , pp. 11260-11262
  • 17
    • 0001184883 scopus 로고    scopus 로고
    • International Conference on Harmonization
    • Q2B: Validation of Analytical Procedures: Methodology, Availability
    • Q2B: Validation of Analytical Procedures: Methodology, Availability. In International Conference on Harmonization. Federal Register 1997; 62(96): 27463-27467.
    • (1997) Federal Register , vol.62 , Issue.96 , pp. 27463-27467
  • 18
    • 85067141768 scopus 로고    scopus 로고
    • FDA: Analytical Procedures and Methods Validation: Chemistry, Manufacturing and Controls Documentation; Availability. Federal Register (Notices)
    • FDA: Analytical Procedures and Methods Validation: Chemistry, Manufacturing and Controls Documentation; Availability. Federal Register (Notices), 2000; 65(169): 52776-52777.
    • (2000) , vol.65 , Issue.169 , pp. 52776-52777
  • 19
    • 79957913223 scopus 로고    scopus 로고
    • Development and validation of RP-HPLC method for determination of Raloxifene Hydrochloride from pharmaceutical preparation
    • Vijay Kumar B, Pratap Kumar K, Suresh K, Saheena A, Srikanth P, Suneetha Y. Development and validation of RP-HPLC method for determination of Raloxifene Hydrochloride from pharmaceutical preparation. J Chem Pharm Res, 2011; 3(3):784-791. [www.fda.gov/cder/guidance/cmc3.pdf].
    • (2011) J Chem Pharm Res , vol.3 , Issue.3 , pp. 784-791
    • Vijay, K.B.1    Pratap, K.K.2    Suresh, K.3    Saheena, A.4    Srikanth, P.5    Suneetha, Y.6
  • 20
    • 85067141829 scopus 로고    scopus 로고
    • USP 25-NF 20, Validation of Compendial Methods Section (1225) (United States Pharmacopeal Convention, Rockville, Maryland, USA
    • USP 25-NF 20, Validation of Compendial Methods Section (1225) (United States Pharmacopeal Convention, Rockville, Maryland, USA, 2002) p 2256.
    • (2002) , pp. 2256
  • 21
    • 0037435988 scopus 로고    scopus 로고
    • Validation of HPLC Chromatography Methods for Pharmaceutical Analysis. Understanding the Differences and Similarities between Validation Requirements of FDA, the US Pharmacopeia and the ICH
    • Shabir GA. Validation of HPLC Chromatography Methods for Pharmaceutical Analysis. Understanding the Differences and Similarities between Validation Requirements of FDA, the US Pharmacopeia and the ICH. J Chromatogr A, 2003; 987(1-2): 57-66.
    • (2003) J Chromatogr A , vol.987 , Issue.1-2 , pp. 57-66
    • Shabir, G.A.1
  • 22
    • 0029961418 scopus 로고    scopus 로고
    • Medicare Program; Changes to the Hospital Outpatient Prospective
    • Wood CE. Medicare Program; Changes to the Hospital Outpatient Prospective. Med J Aust, 1996; 165: 510-514.
    • (1996) Med J Aust , vol.165 , pp. 510-514
    • Wood, C.E.1
  • 23
    • 77957551491 scopus 로고    scopus 로고
    • Validation of analytical methods - strategies & importance
    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: definitions and terminology, Geneva (1996) adopted by
    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: definitions and terminology, Geneva (1996) adopted by Ravichandran V, Shalini S, Sundram KM, Harish R. Validation of analytical methods - strategies & importance. Int J Pharmacy and Pharm Sci, 2003; 2(3): 18-22.
    • (2003) Int J Pharmacy and Pharm Sci , vol.2 , Issue.3 , pp. 18-22
    • Ravichandran, V.1    Shalini, S.2    Sundram, K.M.3    Harish, R.4
  • 24
    • 85067141214 scopus 로고    scopus 로고
    • U.S. FDA, Title 21 of the U.S. Code of Federal Regulations: 21 CFR 211-Current good manufacturing practice for finished pharmaceuticals
    • U.S. FDA, Title 21 of the U.S. Code of Federal Regulations: 21 CFR 211-Current good manufacturing practice for finished pharmaceuticals. [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm].
  • 25
    • 85067142272 scopus 로고    scopus 로고
    • U.S. FDA - Guidance for Industry (draft) Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls and Documentation
    • U.S. FDA - Guidance for Industry (draft) Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls and Documentation, 2000 [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122858.pdf].
    • (2000)
  • 26
    • 85067141486 scopus 로고    scopus 로고
    • ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
    • ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, 2005 [http://www.a2la.org/requirements/req17025.pdf].
    • (2005)
  • 27
    • 77957019706 scopus 로고    scopus 로고
    • Development, validation and transfer of a near infrared method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product
    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: Methodology, adopted in 1996, Geneva adopted by
    • International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: Methodology, adopted in 1996, Geneva adopted by Peinado A, Hammond J, Scott A. Development, validation and transfer of a near infrared method to determine in-line the end point of a fluidised drying process for commercial production batches of an approved oral solid dose pharmaceutical product. J Pharm Biomed Anal. 2011, 5; 54(1):13-20.
    • (2011) J Pharm Biomed Anal , vol.5 , Issue.1 , pp. 13-20
    • Peinado, A.1    Hammond, J.2    Scott, A.3
  • 28
    • 85067140935 scopus 로고
    • U.S. EPA, Guidance for methods development and methods validation for the Resource Conservation and Recovery Act (RCRA) Program, Washington, D.C
    • U.S. EPA, Guidance for methods development and methods validation for the Resource Conservation and Recovery Act (RCRA) Program, Washington, D.C. (1995). [http://www.epa.gov/sw-846/pdfs/methdev.pdf].
    • (1995)
  • 29
    • 40149095611 scopus 로고    scopus 로고
    • Medicare Part D: Selected Issues for Plan Sponsors, Pharmacists, and Beneficiaries in 2008
    • General Chapter 1225, Validation of compendial methods, United States Pharmacopeia 30, National Formulary 25, Rockville, Md., USA, The United States Pharmacopeial Convention, Inc., (2007) adopted by
    • General Chapter 1225, Validation of compendial methods, United States Pharmacopeia 30, National Formulary 25, Rockville, Md., USA, The United States Pharmacopeial Convention, Inc., (2007) adopted by Ronnie DP, JoAnn S. Medicare Part D: Selected Issues for Plan Sponsors, Pharmacists, and Beneficiaries in 2008. J Manag Care Pharm, 2008; 14(1): 50-60.
    • (2008) J Manag Care Pharm , vol.14 , Issue.1 , pp. 50-60
    • Ronnie, D.P.1    Joann, S.2
  • 30
    • 34249653094 scopus 로고    scopus 로고
    • Development and validation of an HPLC method for the determination of dibenzoylmethane in rat plasma and its application to the pharmacokinetic study
    • U.S. FDA - Guidance for Industry, Bioanalytical Method Validation adopted by
    • U.S. FDA - Guidance for Industry, Bioanalytical Method Validation adopted by Shen G, Hong JL, Kong AN. Development and validation of an HPLC method for the determination of dibenzoylmethane in rat plasma and its application to the pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci, 2007; 852(1-2): 56-61.
    • (2007) J Chromatogr B Analyt Technol Biomed Life Sci , vol.852 , Issue.1-2 , pp. 56-61
    • Shen, G.1    Hong, J.L.2    Kong, A.N.3
  • 31
    • 0000069766 scopus 로고
    • A life cycle approach to the validation of analytical methods during pharmaceutical product development, Part I: The initial validation process
    • Hokanson GC. A life cycle approach to the validation of analytical methods during pharmaceutical product development, Part I: The initial validation process. Pharm. Tech. 1994, pp. 118-130.
    • (1994) Pharm. Tech , pp. 118-130
    • Hokanson, G.C.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.