Capillary Electrophoresis with Diode Array Detection for the Quantification of Triptorelin and Lanreotide in Pharmaceutical Quality Control: Development, Validation, Greenness and Practicality Evaluation Cover

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Capillary Electrophoresis with Diode Array Detection for the Quantification of Triptorelin and Lanreotide in Pharmaceutical Quality Control: Development, Validation, Greenness and Practicality Evaluation

European Pharmaceutical Journal

Volume 71 (2024): Issue 2 (December 2024)

By: O. Stefanik, P. Mikus and J. Piestansky

Open Access

|Dec 2024

Figures & Tables

Electropherograms illustrating the simultaneous analysis of lanreotide (L) and triptorelin (T) at their LOQ concentration level (2 mg/mL) in the aqueous matrix, comparing wavelengths: (a) 220 nm and (b) 200 nm. LOQ, limit and quantification.

Electropherogram depicting the analysis of Diphereline® with expected triptorelin content at the concentration level of 5 mg/mL after dilution.

Greenness and applicability comparison of CE methods developed for lanreotide and triptorelin analysis: CE-MS (Piešťanský et al., 2021), CZE-UV (Stefanik et al., 2024b), and CZE-DAD (present study) using GAPI, AGREE, and BAGI metrics. AGREE, analytical GREEnness; BAGI, Blue Applicability Grade Index; CE-MS, capillary electrophoresis-mass spectrometry; CZE-DAD, capillary zone electrophoresis with diode-array detection; GAPI, Green Analytical Procedure Index.

Precision and accuracy of the CZE-DAD method for lanreotide and triptorelin quantification_

		Lanreotide			Triptorelin
	Nominal (µg/mL)	Found (µg/mL)	RSD (%)	RE (%)	Found (µg/mL)	RSD (%)	RE (%)
Intraday, n = 4	2	2.07	1.6	3.4	2.12	1.6	6.2
	4	3.96	2.8	−1.0	3.71	2.6	−7.3
	8	7.82	3.5	−2.3	8.13	7.1	1.7
	12	12.25	3.1	2.1	12.18	4.0	1.5
	16	15.90	3.6	−0.6	15.86	5.5	−0.9
Interday, n = 12	2	2.19	6.7	9.7	2.27	4.1	13.6
	4	3.94	6.2	−1.4	3.88	4.2	−2.9
	8	7.69	4.5	−3.9	7.53	3.7	−5.9
	12	12.12	4.6	1.0	12.34	3.7	2.9
	16	16.06	2.7	0.4	15.97	2.8	−0.2

Optimization of BGE composition for the determination of lanreotide and triptorelin via CZE-DAD_

	Lanreotide, n =3				Triptorelin, n =3
BGE	pH	RSD_tm (%)	RSD_area (%)	N	RSD_tm (%)	RSD_area (%)	N
50 mmol/L HFo	2.54	16.9	22.1	44,312	17.8	21.6	39,420
100 mmol/L HFo	2.38	1.7	2.8	75,129	1.6	2.6	74,069
250 mmol/L HFo	2.18	0.9	0.9	109,590	0.9	0.4	106,053
500 mmol/L HFo	2.03	0.4	1.8	94,823	0.3	1.6	92,521
1000 mmol/L HFo	1.88	4.9	4.5	95,303	5.1	7.5	97,016
100 mmol/L HFo + 100 mmol/L HAc	2.63	0.5	2.1	38,430	0.5	2.4	31,340
250 mmol/L HFo + 250 mmol/L HAc	2.43	1.1	4.2	71,222	1.0	2.2	63,824

CZE-DAD operation and calibration parameters for lanreotide and triptorelin analysis in an aqueous matrix_

Parameter	Lanreotide	Triptorelin
t_m (min)	3.95	4.35
RSDtm (%), n = 4	0.21	0.23
RSD_area (%), n = 4	1.64	1.64
Regression equation	y = 13.427x − 6.0741	y = 13.537x − 8.5831
r²	0.996	0.991
Linear range (μg/mL)	2–16	2–16
LOD (μg/mL)	0.5	0.5
LOQ (μg/mL)	2	2
N	34,606	29,079

Short-term stability assessment of lanreotide and triptorelin standards in aqueous solutions_

Storage conditions (°C)	Sample/fresh solution peak area ratio
Storage conditions (°C)	Lanreotide, n = 4	Triptorelin, n = 4
20	0.81 ± 0.08	0.83 ± 0.12
4	0.87 ± 0.06	1.02 ± 0.08
−20	0.94 ± 0.10	1.05 ± 0.02

DOI: https://doi.org/10.2478/afpuc-2024-0012 | Journal eISSN: 2453-6725

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Language: English

Page range: 7 - 15

Submitted on: Aug 22, 2024

Accepted on: Oct 8, 2024

Published on: Dec 1, 2024

Published by: Comenius University in Bratislava, Faculty of Pharmacy

In partnership with: Paradigm Publishing Services

Publication frequency: 2 issues per year

Keywords:

capillary zone electrophoresis,

green analytical chemistry,

pharmaceutical quality control,

Related subjects:

Pharmacy, other

© 2024 O. Stefanik, P. Mikus, J. Piestansky, published by Comenius University in Bratislava, Faculty of Pharmacy
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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