Development of Two Novel One-Step and Green Microwell Spectrophotometric Methods for High-Throughput Determination of Ceritinib, a Potent Drug for Treatment of Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer
Abstract
:1. Background and Objectives
2. Materials and Methods
2.1. Apparatus
2.2. Chemicals and Materials
2.3. Preparation of Solutions
2.3.1. Standard CER Solution
2.3.2. Capsule Sample Solution
2.4. Recommended Procedures of MW-SPMs
2.5. Determination of Reaction Molar Ratio
2.6. Content Uniformity Testing for Zykadia® Capsules
3. Results and Discussion
3.1. Strategy for Selection of Reagents and Reactions
3.2. Methodology Selection and Design
3.3. Absorption Spectra and Nature of Reactions
3.4. Optimum Reaction Conditions
3.5. Molar Ratios and Reaction Mechanisms
3.6. Development and Validation of MW-SPMs
3.6.1. Linear Range and Sensitivity
3.6.2. Precision and Accuracy
3.6.3. Specificity and Interference
3.6.4. Robustness and Ruggedness
3.7. Analysis of Zykadia® Capsules and Content Uniformity Testing
3.8. Greenness Levels of MW-SPMs
3.9. Comparison of Greenness Levels of MW-SPMs with Reported Methods
3.10. Throughputs of MW-SPMs
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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OBQ | DDQ | |||
---|---|---|---|---|
Condition | Studied Range | Optimum Value | Studied Range | Optimum Value |
Reagent conc. (%, w/v) | 0.05–1.2 | 0.5 | 0.05–1.2 | 1 |
Solvent | Different a | Methanol | Different a | Methanol |
Reaction time (min) | 0–25 | 10 | 0–25 | 5 |
λmax (nm) | 400–800 | 540 | 400–800 | 460 |
Atom Number | Atom Type | Charge | Atom Number | Atom Type | Charge |
---|---|---|---|---|---|
C(1) | Alkyl carbon, SP3 | 0.27 | N(24) | Aromatic nitrogen with s lone pair | −0.62 |
N(2) | Amine nitrogen | −0.9 | N(25) | Enamine or aniline nitrogen, Deloc. LP | −0.6 |
C(3) | Alkyl carbon, SP3 | 0.27 | C(26) | Aromatic carbon, in benzene, pyridine | 0.1 |
C(4) | Alkyl carbon, SP3 | 0 | C(27)–C(30) | Aromatic carbon, in benzene, pyridine | −0.15 |
C(5) | Alkyl carbon, SP3 | 0.1435 | C(31) | Aromatic carbon, in benzene, pyridine | −0.009 |
C(6) | Alkyl carbon, SP3 | 0 | S(32) | Sulfone sulfur | 1.2038 |
C(7)–C8 | Aromatic carbon, in benzene, pyridine | −0.1435 | C(33) | Alkyl carbon, SP3 | 0.1052 |
C(9) | Aromatic carbon, in benzene, pyridine | −0.15 | C(34)–C(35) | Alkyl carbon, SP3 | 0 |
C(10) | Aromatic carbon, in benzene, pyridine | 0.1 | O(36)–O(37) | Terminal O’s on sulfur | −0.65 |
C(11) | Aromatic carbon, in benzene, pyridine | 0.0825 | C(38) | Alkyl carbon, SP3 | 0.36 |
C(12) | Aromatic carbon, in benzene, pyridine | −0.15 | H(39)–H(40) | H attached to C | 0 |
C(13) | Alkyl carbon, SP3 | 0.1435 | H(41) | Generic H on SP3 nitrogen in amine | 0.36 |
O(14) | Ether oxygen | −0.3625 | H(42)–H(48) | H attached to C | 0 |
C(15) | Alkyl carbon, SP3 | 0.28 | H(49)–H(50) | H on enamine N | 0.15 |
C(16)–C(17) | Alkyl carbon, SP3 | 0 | H(51)–H(60) | H attached to C | 0 |
N(18) | Enamine or aniline nitrogen, Deloc. LP | −0.6 | H(61) | Hydrogen in H-N-C=N moiety | 0.4 |
C(19) | Aromatic carbon, in benzene, pyridine | 0.72 | H(62) | H attached to C | 0.15 |
N(20) | Aromatic carbon, in benzene, pyridine | −0.62 | H(63) | Hydrogen on enamine nitrogen | 0.4 |
C(21) | Aromatic carbon, in benzene, pyridine | 0.16 | H(64)–H(67) | H attached to C | 0.15 |
C(22) | Aromatic carbon, in benzene, pyridine | −0.1435 | H(68)–H(81) | H attached to C | 0 |
C(23) | Aromatic carbon, in benzene, pyridine | 0.41 |
Parameter | Value | |
---|---|---|
OBQ | DDQ | |
Linear range (µg/well) | 5–150 | 10–200 |
Intercept | 0.0052 | 0.0171 |
Slope | 0.0068 | 0.0043 |
Determination coefficient (r2) | 0.9994 | 0.9992 |
Limit of detection (µg/well) | 2.2 | 3.4 |
Limit of quantitation (µg/well) | 6.5 | 10.2 |
CER Concentration (µg/well) | Intraday (n = 3) | Interday (n = 6) | ||
---|---|---|---|---|
Recovery (% ± RSD) | Error (%) | Recovery (% ± RSD) | Error (%) | |
OBQ | ||||
20 | 101.2 ± 1.3 | 1.2 | 99.6 ± 1.3 | −0.4 |
80 | 99.8 ± 1.2 | −0.4 | 100.6 ± 1.1 | 0.6 |
120 | 100.1 ± 1.4 | 0.1 | 99.8 ± 1.3 | −0.2 |
DDQ | ||||
25 | 102.1 ± 1.2 | 2.1 | 101.2 ± 1.2 | 1.2 |
100 | 99.4 ± 0.9 | −0.8 | 99.5 ± 0.8 | −0.6 |
180 | 100.4 ± 1.3 | 0.4 | 100.8 ± 1.6 | 0.8 |
Nominated CER Concentration (µg/well) | Label Claim (% ± RSD) a | ||
---|---|---|---|
OBQ | DDQ | ||
50 | 99.6 ± 1.3 | 100.4 ± 1.4 | |
100 | 100.2 ± 1.4 | 98.8 ± 1.2 | |
150 | 101.5 ± 1.6 | 99.5 ± 1.0 | |
Mean | 100.4 ± 1.0 | 99.6 ± 0.8 |
Capsule Number | Label Claim (%) | |
---|---|---|
OBQ | DDQ | |
1 | 99.5 ± 1.2 | 101.5 ± 1.5 |
2 | 99.2 ± 2.3 | 100.2 ± 1.2 |
3 | 102.5 ± 1.8 | 98.8 ± 0.8 |
4 | 98.8 ± 1.4 | 100.2 ± 1.4 |
5 | 97.9 ± 1.9 | 99.5 ± 2.1 |
6 | 100.6 ± 1.5 | 97.8 ± 2.2 |
7 | 101.2 ± 0.9 | 101.7 ± 1.4 |
8 | 98.4 ± 1.3 | 100.2 ± 0.6 |
9 | 100.8 ± 0.9 | 99.5 ± 0.8 |
10 | 98.2 ± 1.3 | 101.8 ± 1.2 |
Mean | 99.7 | 100.1 |
SD | 1.5 | 1.3 |
Acceptance value | 3.6 | 3.1 |
Maximum allowed value | 15 | 15 |
Eco-Scale Score Parameters | Penalty Points (PPs) |
---|---|
Amount of solvent/reagent | |
Solvent: <1 mL (mL (g) per sample) | 1 |
Reagent: <1 mL (mL (g) per sample) | 1 |
∑ = 2 | |
Hazard of solvent/reagent | |
Solvent: methanol | 3 |
Reagent: OBQ and DDQ | 3 |
∑ = 6 | |
Instrument: energy used (kWh per sample) | |
Microplate reader | 0 |
∑ = 0 | |
Occupational hazards | |
Analytical process is hermetic | 0 |
Emission of vapors and gases to the air | 0 |
∑ = 0 | |
Waste | |
Production (<1 mL (g) per sample) | 1 |
Treatment (no treatment involved) | 3 |
∑ = 4 | |
Total PPs | 12 |
Eco-Scale score | 88 |
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Abuhejail, R.M.; Alzoman, N.Z.; Darwish, I.A. Development of Two Novel One-Step and Green Microwell Spectrophotometric Methods for High-Throughput Determination of Ceritinib, a Potent Drug for Treatment of Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer. Medicina 2023, 59, 1813. https://doi.org/10.3390/medicina59101813
Abuhejail RM, Alzoman NZ, Darwish IA. Development of Two Novel One-Step and Green Microwell Spectrophotometric Methods for High-Throughput Determination of Ceritinib, a Potent Drug for Treatment of Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer. Medicina. 2023; 59(10):1813. https://doi.org/10.3390/medicina59101813
Chicago/Turabian StyleAbuhejail, Reem M., Nourah Z. Alzoman, and Ibrahim A. Darwish. 2023. "Development of Two Novel One-Step and Green Microwell Spectrophotometric Methods for High-Throughput Determination of Ceritinib, a Potent Drug for Treatment of Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer" Medicina 59, no. 10: 1813. https://doi.org/10.3390/medicina59101813