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LC-MS/MS assay for quantitation of enalapril and enalaprilat in plasma for bioequivalence study in Indian subjects.
Halder, Dhiman; Dan, Shubhasis; Pal, Murari Mohun; Biswas, Easha; Chatterjee, Nilendra; Sarkar, Pradipta; Halder, Umesh Chandra; Pal, Tapan Kumar.
Affiliation
  • Halder D; Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India; Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
  • Dan S; Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India; Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
  • Pal MM; TAAB Biostudy Services, Kolkata 700032, India; TAAB Biostudy Services, Kolkata 700032, India.
  • Biswas E; Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India; Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
  • Chatterjee N; TAAB Biostudy Services, Kolkata 700032, India; TAAB Biostudy Services, Kolkata 700032, India.
  • Sarkar P; Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India; Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
  • Halder UC; Organic Chemistry Section, Department of Chemistry, Jadavpur University, Kolkata, India; Organic Chemistry Section, Department of Chemistry, Jadavpur University, Kolkata, India.
  • Pal TK; Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India; Bioequivalence Study Centre, Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
Future Sci OA ; 3(1): FSO165, 2017 Mar.
Article in En | MEDLINE | ID: mdl-28344828
ABSTRACT

BACKGROUND:

Enalapril (EPL) is an angiotensin-converting enzyme inhibitor for the treatment of hypertension and chronic heart failure. Enalaprilat (EPLT) is an active metabolite that contributes to the overall activity of EPL.

AIM:

To quantitate EPL along with its metabolite EPLT using LC-MS/MS, a bioanalytical method was developed and validated with tolbutamide in human plasma using a protein precipitation technique.

RESULTS:

The sensitive and selective method has an LLOQ of 1 ng/ml with a linearity range of 1-500 ng/ml for both EPL and EPLT using 300 µl of plasma without any matrix effect.

CONCLUSION:

Linearity, specificity, accuracy, precision and stability, as well as its application to the analysis of plasma samples after oral administration of 20 mg of EPL maleate in healthy volunteers demonstrate applicability to bioavailability/bioequivalence studies.
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Full text: 1 Database: MEDLINE Language: En Year: 2017 Type: Article
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Full text: 1 Database: MEDLINE Language: En Year: 2017 Type: Article