Opportunities of Amlodipine as a Potential Candidate in the Evaluation of Drug Compliance during Antihypertensive Therapy
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Subjects
2.2. Statistical Methods
2.3. Method Validation
3. Results
3.1. Results from Participant Surveys
3.2. Results of AML and DAML Validation
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Appendix A
Appendix A.1. Method Validation
Chromatographic Parameters | |||
---|---|---|---|
Column | Acquity UPLC BEH C18 (2.1 × 50 mm, 1.7 μm) | ||
Mobile phase | A: 0.1% aqueous formic acid B: acetonitrile | ||
Gradient | linear, 0 min—25% B, 1.5 min—98% B, 3.0 min—98% B, 3.5 min—25% B, 5.0 min—25% B | ||
Flow rate | 0.4 mL/min | ||
Column temperature | 40 °C | ||
Injection volume | 5 µL | ||
Mass spectrometer parameters | |||
Ionization | positive electrospray | ||
Capillary voltage | 3.0 kV | ||
Ion source temperature | 140 °C | ||
Desolvation gas (N2) flow | 1000 L/h | ||
Desolvation temperature | 600 °C | ||
MRM parameters | |||
Compound | MRM transition | Cone voltage, V | Collision energy, (eV) |
AML | 409.0 > 238.0 409.0 > 294.0 | 30 30 | 10 10 |
DAML | 407.0 > 286.0 | 30 | 25 |
Appendix A.2. Reagents
Appendix A.3. Sample Preparation
Appendix A.4. Sample Preparation for UPLC/MS/MS Analysis
Appendix A.5. Results of AML and DAML Validation
Appendix A.5.1. Selectivity
Plasma Source | %, Response Blank Plasma vs. Spiked Plasma at LLOQ | |
---|---|---|
AML | DAML | |
1 | 4.2 | 0.2 |
2 | 4.0 | 1.9 |
3 | 3.1 | 1.7 |
4 | 3.3 | 2.2 |
5 | 4.5 | 1.9 |
6 | 3.5 | 1.8 |
Appendix A.5.2. Carry-Over
Appendix A.5.3. The Lowest Limit of Quantification
Plasma Source | Signal to Noise | |
---|---|---|
AML | DAML | |
1 | 24 | 45 |
2 | 25 | 52 |
3 | 32 | 58 |
4 | 30 | 45 |
5 | 22 | 51 |
6 | 28 | 56 |
Appendix A.5.4. Linearity
Standard Level | Nominal Conc., ng/mL | Day 1 | Day 2 | Day 3 | |||
---|---|---|---|---|---|---|---|
Back Calc. Conc., ng/mL | Conc. Dev., % | Back Calc. Conc., ng/mL | Conc. Dev., % | Back Calc. Conc., ng/mL | Conc. Dev., % | ||
1 | 1 | 0.91 | −8.8 | 1.16 | 15.5 | 1.09 | 9.0 |
1.09 | 9.0 | 1.12 | 11.9 | 1.05 | 5.3 | ||
1.10 | 10.0 | 1.11 | 11.0 | 1.10 | 10.4 | ||
2 | 2 | 2.07 | 3.7 | 1.98 | −1.0 | 2.04 | 2.0 |
1.97 | −1.6 | 1.83 | −8.4 | 1.94 | −3.2 | ||
1.94 | −3.1 | 1.77 | −11.3 | 2.10 | 5.1 | ||
3 | 5 | 4.96 | −0.8 | 4.96 | −0.7 | 4.90 | −2.1 |
5.04 | 0.7 | 4.69 | −6.3 | 4.76 | −4.8 | ||
5.03 | 0.6 | 4.98 | −0.4 | 4.64 | −7.3 | ||
4 | 10 | 9.76 | −2.4 | 9.96 | −0.4 | 9.50 | −5.0 |
9.66 | −3.4 | 9.56 | −4.4 | 9.32 | −6.8 | ||
9.50 | −5.0 | 9.40 | −6.0 | 9.50 | −5.0 | ||
5 | 25 | 24.57 | −1.7 | 24.63 | −1.5 | 24.50 | −2.0 |
24.64 | −1.4 | 24.43 | −2.3 | 25.22 | 0.9 | ||
25.40 | 1.6 | 24.82 | −0.7 | 24.32 | −2.7 | ||
6 | 50 | 50.12 | 0.2 | 51.02 | 2.0 | 51.25 | 2.5 |
51.27 | 2.5 | 51.26 | 2.5 | 50.91 | 1.8 | ||
49.98 | 0.0 | 50.32 | 0.6 | 50.87 | 1.7 | ||
Calibration curve parameters | |||||||
Day 1 | Day 2 | Day 3 | |||||
A | 478.63 | 412.26 | 378.34 | ||||
B | −55.19 | −96.62 | −98.69 | ||||
r2 | 0.9994 | 0.9989 | 0.9988 |
Standard Level | Nominal Conc., ng/mL | Day 1 | Day 2 | Day 3 | |||
---|---|---|---|---|---|---|---|
Back Calc. Conc., ng/mL | Conc. Dev., % | Back Calc. Conc., ng/mL | Conc. Dev., % | Back Calc. Conc., ng/mL | Conc. Dev., % | ||
1 | 1 | 1.05 | 5.3 | 1.04 | 3.5 | 1.02 | 2.1 |
1.05 | 5.0 | 1.03 | 3.1 | 1.03 | 3.0 | ||
1.04 | 3.7 | 1.03 | 3.3 | 1.04 | 3.7 | ||
2 | 2 | 1.95 | −2.7 | 1.97 | −1.5 | 2.01 | 0.4 |
1.94 | −2.9 | 2.00 | 0.1 | 2.03 | 1.4 | ||
2.01 | 0.4 | 1.99 | −0.6 | 2.05 | 2.4 | ||
3 | 5 | 4.94 | −1.3 | 4.89 | −2.2 | 4.85 | −3.0 |
4.98 | −0.4 | 4.92 | −1.6 | 4.89 | −2.2 | ||
4.79 | −4.2 | 4.89 | −2.3 | 4.90 | −2.1 | ||
4 | 10 | 9.99 | −0.1 | 9.70 | −3.0 | 9.79 | −2.2 |
9.77 | −2.3 | 9.99 | −0.1 | 9.78 | −2.2 | ||
9.88 | −1.2 | 9.75 | −2.5 | 9.62 | −3.8 | ||
5 | 25 | 25.16 | 0.6 | 25.38 | 1.5 | 25.19 | 0.8 |
24.72 | −1.1 | 25.55 | 2.2 | 25.22 | 0.9 | ||
24.85 | −0.6 | 25.20 | 0.8 | 24.83 | −0.7 | ||
6 | 50 | 49.66 | −0.7 | 49.60 | −0.8 | 51.02 | 2.0 |
50.33 | 0.7 | 49.35 | −1.3 | 50.17 | 0.3 | ||
50.91 | 1.8 | 50.73 | 1.5 | 49.58 | −0.8 | ||
Calibration curve parameters | |||||||
Day 1 | Day 2 | Day 3 | |||||
A | 1750.97 | 1587.51 | 1419.38 | ||||
B | −235.98 | −264.37 | −233.04 | ||||
r2 | 0.9998 | 0.9997 | 0.9997 |
Appendix A.5.5. Accuracy and Precision
QC Level, Conc., ng/mL | Day 1 | Day 2 | Day 3 | Between-Run | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Mean Conc., ng/mL | RE, % | CV, % | Mean Conc., ng/mL | RE, % | CV, % | Mean Conc., ng/mL | RE, % | CV, % | Mean Conc., ng/mL | RE, % | CV, % | |
LLOQ 1.0 ng/mL | 0.98 | −1.80 | 3.68 | 1.09 | 9.10 | 6.38 | 1.15 | 15.11 | 3.36 | 1.07 | 7.48 | 8.01 |
LQC 2.5 ng/mL | 2.31 | −7.40 | 4.70 | 2.64 | 1.70 | 2.69 | 2.62 | 4.96 | 3.72 | 2.49 | −0.25 | 6.45 |
MQC 20.0 ng/mL | 17.61 | −12.00 | 0.70 | 19.83 | −0.90 | 2.61 | 20.11 | 0.57 | 1.20 | 19.18 | −4.08 | 6.26 |
HQC 40.0 ng/mL | 35.44 | −11.40 | 0.69 | 39.96 | −0.10 | 1.26 | 41.22 | 3.04 | 1.69 | 38.87 | −2.82 | 6.71 |
QC Level, Conc., ng/mL | Day 1 | Day 2 | Day 3 | Between-Run | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Mean Conc., ng/mL | RE, % | CV, % | Mean Conc., ng/mL | RE, % | CV, % | Mean Conc., ng/mL | RE, % | CV, % | Mean Conc., ng/mL | RE, % | CV, % | |
LLOQ 1.0 ng/mL | 1.07 | 7.20 | 2.99 | 1.14 | 14.00 | 2.07 | 1.15 | 15.06 | 4.14 | 1.12 | 12.08 | 4.35 |
LQC 2.5 ng/mL | 2.53 | 1.20 | 3.45 | 2.66 | 6.40 | 1.80 | 2.68 | 7.34 | 4.14 | 2.63 | 5.01 | 4.03 |
MQC 20.0 ng/mL | 18.77 | −6.20 | 1.19 | 20.04 | 0.20 | 1.56 | 20.93 | 4.66 | 0.84 | 19.91 | −0.43 | 4.75 |
HQC 40.0 ng/mL | 37.83 | −5.40 | 1.10 | 39.98 | −1.60 | 2.10 | 41.92 | 4.79 | 0.85 | 39.71 | −0.73 | 4.59 |
Appendix A.5.6. Matrix Effect
Analyte | QC Level, Conc., ng/mL | Plasma Source | Matrix Effect | Average Matrix Effect | CV, % |
---|---|---|---|---|---|
AML | LQC 2.5 ng/mL | 1 | 1.06 | 1.01 | 3.7 |
2 | 1.03 | ||||
3 | 1.04 | ||||
4 | 0.96 | ||||
5 | 1.00 | ||||
6 | 0.98 | ||||
HQC 40.0 ng/mL | 1 | 1.03 | 1.02 | 2.0 | |
2 | 1.05 | ||||
3 | 1.00 | ||||
4 | 1.00 | ||||
5 | 1.00 | ||||
6 | 1.02 | ||||
DAML | LQC 2.5 ng/mL | 1 | 1.15 | 1.07 | 4.1 |
2 | 1.08 | ||||
3 | 1.06 | ||||
4 | 1.04 | ||||
5 | 1.03 | ||||
6 | 1.04 | ||||
HQC 40.0 ng/mL | 1 | 1.13 | 1.01 | 6.4 | |
2 | 0.98 | ||||
3 | 0.96 | ||||
4 | 1.01 | ||||
5 | 0.95 | ||||
6 | 1.04 |
Appendix A.5.7. Stability
QC Level, Conc., ng/mL | AML | DAML | ||
---|---|---|---|---|
Average Concentration Found, ng/mL | Stability, % | Average Concentration Found, ng/mL | Stability, % | |
LQC 2.5 ng/mL | 2.11 | 82.4 | 2.42 | 96.7 |
HQC 40.0 ng/mL | 34.80 | 87.0 | 36.49 | 91.2 |
QC Level, Conc., ng/mL | AML | DAML | ||
---|---|---|---|---|
Average Concentration Found, ng/mL | Stability, % | Average Concentration Found, ng/mL | Stability, % | |
LQC 2.5 ng/mL | 2.82 | 112.8 | 2.80 | 112.1 |
HQC 40.0 ng/mL | 41.39 | 103.5 | 41.67 | 104.2 |
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Characteristics | Value |
---|---|
Women, n (%) | 31 (38.7) |
Men, n (%) | 50 (61.7) |
Mean age, years ± SD: | 66.6 ± 9.1 |
| 69.8 ± 8.0 |
| 64.6 ± 9.2 |
Antihypertensive drug combination containing AML, n (%) | |
| 11 (13.6) |
| 40 (49.4) |
| 30 (37.0) |
Dose of AML (mg), n (%) | |
| 7 (8.6) |
| 50 (61.7) |
| 24 (30.9) |
Results | Age Group | |||
---|---|---|---|---|
<65 Years (%) | ≥65 Years (%) | |||
Total | 36 | 45 | ||
Female | 8 (22.2) | 23 (51.1) | ||
Male | 28 (77.8) | 22 (48.9) | ||
BMI, kg/m2 | Women | 18.5–24.99 | 0 (0) | 1 (2.2) |
>25–29.99 | 4 (11.1) | 10 (22.2) | ||
≥30 | 4 (11.1) | 12 (26.7) | ||
Men | 18.5–24.99 | 5 (13.9) | 6 (13.3) | |
>25–29.99 | 11 (30.6) | 8 (2.2) | ||
≥30 | 12 (33.3) | 8 (17.8) | ||
Respondents that reached target SBP (measurement in hospital) | 17 (47.2) | 28 (62.2) | ||
Respondents that reached target SBP (measurement at home *) | 14 (38.8) | 32 (71.1) | ||
Respondents that reached target DBP (measurement in hospital) | 14 (38.9) | 36 (80.0) | ||
Respondents that reached target DBP (measurement at home *) | 11 (35.5) | 43 (97.7) | ||
AML formulations of patients with reached target SBP (<130 mm Hg at the age <65 years; <140 mm Hg at the age ≥65) | Single | 3 (8.3) | 4 (8.9) | |
Two component FDC | 7 (19.4) | 17 (37.8) | ||
Three component FDC | 7 (19.4) | 7 (15.6) | ||
Respondents that failed to reach target SYS blood pressure (measurement in hospital) | 19 (52.8) | 17 (37.8) | ||
Respondents that failed to reach target SYS blood pressure (measurement at home *) | 17 (54.8) | 12 (26.7) | ||
Respondents that failed to reach target DBP (measurement in hospital) | 22 (61.1) | 9 (20.0) | ||
Respondents that failed to reach target DBP (measurement at home *) | 20 (64.5) | 1 (2.3) | ||
AML formulations of patients with non-reached target SBP (>130 mm Hg at the age <65 years; >140 mm Hg at the age ≥65) | Single | 2 (5.6) | 2 (4.4) | |
Two component FDC | 9 (25.0) | 7 (15.6) | ||
Three component FDC | 8 (22.2) | 8 (17.8) | ||
Respondents that forget to take hypertension medications | Women | 2 (5.6) | 7 (15.6) | |
Men | 14 (38.9) | 8 (17.8) |
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Kustovs, D.; Urtāne, I.; Sevostjanovs, E.; Moreino, E.; Trušinskis, K. Opportunities of Amlodipine as a Potential Candidate in the Evaluation of Drug Compliance during Antihypertensive Therapy. Medicina 2023, 59, 340. https://doi.org/10.3390/medicina59020340
Kustovs D, Urtāne I, Sevostjanovs E, Moreino E, Trušinskis K. Opportunities of Amlodipine as a Potential Candidate in the Evaluation of Drug Compliance during Antihypertensive Therapy. Medicina. 2023; 59(2):340. https://doi.org/10.3390/medicina59020340
Chicago/Turabian StyleKustovs, Dmitrijs, Inga Urtāne, Eduards Sevostjanovs, Eva Moreino, and Kārlis Trušinskis. 2023. "Opportunities of Amlodipine as a Potential Candidate in the Evaluation of Drug Compliance during Antihypertensive Therapy" Medicina 59, no. 2: 340. https://doi.org/10.3390/medicina59020340