Development and validation of LC-MSMS method for the analysis of amlodipine and perindopril in tablet dosage form
Introduction: Amlodipine (AMLO) and Perindopril (PER) have been combined in one tablet dosage form which has been proven to be an effective and well tolerated antihypertensive. Many analytical methods were applied for the analysis of AMLO and PER in this combination but most of the methods a...
| Main Authors: | , , , |
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| Format: | Conference or Workshop Item |
| Language: | English |
| Published: |
2018
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| Subjects: | |
| Online Access: | http://irep.iium.edu.my/68161/ http://irep.iium.edu.my/68161/1/IPRC-2018-2.pdf |
| Summary: | Introduction: Amlodipine (AMLO) and Perindopril (PER) have
been combined in one tablet dosage form which has been
proven to be an effective and well tolerated antihypertensive.
Many analytical methods were applied for the analysis of AMLO
and PER in this combination but most of the methods are time
and money consuming. A new sensitive, rapid, and specific LC-
MS/MS analytical methods for the analysis of AMLO and PER
was developed and validated. Chromatographic conditions for
the best results were optimized using design of experiment
method.
4 TH PHARMACEUTICAL RESEARCH CONFERENCE 2018
Challenging The Inquisitive Minds: Frontier Of The Future
24 – 26 August 2018 | Cyberjaya, Malaysia
Method: The instrument used was Waters Aquity UPLC, and
the column was Acquity BEH C18 (50 mm × 2.1 mm, 1.7 µm).
The mobile phase consisted of solvent A which was 0.1% formic
acid in water and solvent B which was ACN. The injected
volume was 10 µl with a flow rate of 0.4 ml/min. samples were
eluted following gradient program over 5 min. The column
temperature was maintained at 35 °C. The detection was
performed using Xevo TQD MS with ESI in positive mode. The
method was validated according to ICH guidelines.
Result: The results showed that the retention times of AMLO
and PER were 1.65 min and 1.78 min respectively. Method was
linear for AMLO and PER over the range of 5-15 ng/ml with R 2
of 0.9988 and 0.9991 respectively. The accuracies of AMLO and
PER were in the range of 98.1% -100.19%. LOD and LOQ were
50.28 and 152.78 pg/ml for AMLO respectively and 16.86 and
51.1 pg/ml for PER respectively. The developed and validated
method was applied for the quantification of AMLO and PER at
tablet dosage form which is available at the market with
satisfactory results.
Conclusion: It can be concluded that this method is highly
sensitive, rapid, selective and it can be used for the routine
analysis of AMLO and PER in QC laboratories. |
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