Bio-analytical method development and validation for ramipril and its metabolite by liquid chromatography- tandem mass spectrometry
By: Gupta, C
.
Contributor(s): Bhardwaj, N.
Publisher: Mumbai Indian Journal of Pharmaceutical Science 2023Edition: Vol.85(4), Jul-Aug.Description: 1126-1136p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Indian journal of pharmaceutical sciencesSummary: Bioanalytical techniques are being widely applied for quantitative estimation of xenobiotics and biotics in
biological matrices such as blood, serum, plasma, proteins or urine. They are crucial for supporting new
drug applications or biologics license applications. Liquid chromatography-tandem mass spectrometry has
become an important tool in pharmaceutical industry as it offers reduced analysis times, improved selectivity
and increased throughput in drug bioanalysis. In the present work attempt has been made to develop a novel
bioanalytical method for estimation of antihypertensive drug Ramipril and its metabolite Ramiprilat in the
plasma samples, by a hyphenated technique which includes liquid chromatography combined with mass
spectrometry, using Enalapril and Enalaprilat as internal standards. The developed method was validated
as per international council for harmonization guidelines for selectivity, specificity, matrix effect, calibration
curve, range, accuracy, precision, dilution integrity and stability etc. It exhibited limit of quantification of
1.09 ng/ml for Ramipril and 1.08 ng/ml for Ramiprilat. The analytes, Ramipril and Ramiprilat were extracted
from plasma by liquid chromatography-tandem mass spectrometry using solvent mixtures comprising of
acetonitrile, methanol and 0.2 % trifluoro acetic acid as mobile phase and Chromolith speed rod RP 18e gold
(50×4.6) column as stationary phase. The validated parameters were within the acceptance criteria as per
the regulatory guidelines and the validated calibration curve exhibited r2 value greater than or equal to 0.98
with high recovery. Hence it can be concluded that the developed method was specific, accurate, sensitive,
and reliable to quantify Ramipril and its metabolite Ramiprilat in biological samples and can be potentially
applied for Pharmacokinetic and bioequivalence studies.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2024-0423 |
Bioanalytical techniques are being widely applied for quantitative estimation of xenobiotics and biotics in
biological matrices such as blood, serum, plasma, proteins or urine. They are crucial for supporting new
drug applications or biologics license applications. Liquid chromatography-tandem mass spectrometry has
become an important tool in pharmaceutical industry as it offers reduced analysis times, improved selectivity
and increased throughput in drug bioanalysis. In the present work attempt has been made to develop a novel
bioanalytical method for estimation of antihypertensive drug Ramipril and its metabolite Ramiprilat in the
plasma samples, by a hyphenated technique which includes liquid chromatography combined with mass
spectrometry, using Enalapril and Enalaprilat as internal standards. The developed method was validated
as per international council for harmonization guidelines for selectivity, specificity, matrix effect, calibration
curve, range, accuracy, precision, dilution integrity and stability etc. It exhibited limit of quantification of
1.09 ng/ml for Ramipril and 1.08 ng/ml for Ramiprilat. The analytes, Ramipril and Ramiprilat were extracted
from plasma by liquid chromatography-tandem mass spectrometry using solvent mixtures comprising of
acetonitrile, methanol and 0.2 % trifluoro acetic acid as mobile phase and Chromolith speed rod RP 18e gold
(50×4.6) column as stationary phase. The validated parameters were within the acceptance criteria as per
the regulatory guidelines and the validated calibration curve exhibited r2 value greater than or equal to 0.98
with high recovery. Hence it can be concluded that the developed method was specific, accurate, sensitive,
and reliable to quantify Ramipril and its metabolite Ramiprilat in biological samples and can be potentially
applied for Pharmacokinetic and bioequivalence studies.
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