PreprintArticleVersion 1Preserved in Portico This version is not peer-reviewed
Development of an HPLC Method through the QbD Approach for the Quantification of Honokiol and Metformin Hydrochloride – Method Validation and Pharmaceutical Applications on Oral Dosage Forms
Version 1
: Received: 5 July 2024 / Approved: 5 July 2024 / Online: 9 July 2024 (06:08:04 CEST)
How to cite:
Sha’at, M.; Spac, A. F.; Stoleriu, I.; Bujor, A.; Cretan, M. S.; Hartan, M.; Ochiuz, L. Development of an HPLC Method through the QbD Approach for the Quantification of Honokiol and Metformin Hydrochloride – Method Validation and Pharmaceutical Applications on Oral Dosage Forms. Preprints2024, 2024070542. https://doi.org/10.20944/preprints202407.0542.v1
Sha’at, M.; Spac, A. F.; Stoleriu, I.; Bujor, A.; Cretan, M. S.; Hartan, M.; Ochiuz, L. Development of an HPLC Method through the QbD Approach for the Quantification of Honokiol and Metformin Hydrochloride – Method Validation and Pharmaceutical Applications on Oral Dosage Forms. Preprints 2024, 2024070542. https://doi.org/10.20944/preprints202407.0542.v1
Sha’at, M.; Spac, A. F.; Stoleriu, I.; Bujor, A.; Cretan, M. S.; Hartan, M.; Ochiuz, L. Development of an HPLC Method through the QbD Approach for the Quantification of Honokiol and Metformin Hydrochloride – Method Validation and Pharmaceutical Applications on Oral Dosage Forms. Preprints2024, 2024070542. https://doi.org/10.20944/preprints202407.0542.v1
APA Style
Sha’at, M., Spac, A. F., Stoleriu, I., Bujor, A., Cretan, M. S., Hartan, M., & Ochiuz, L. (2024). Development of an HPLC Method through the QbD Approach for the Quantification of Honokiol and Metformin Hydrochloride – Method Validation and Pharmaceutical Applications on Oral Dosage Forms. Preprints. https://doi.org/10.20944/preprints202407.0542.v1
Chicago/Turabian Style
Sha’at, M., Mihaela Hartan and Lăcrămioara Ochiuz. 2024 "Development of an HPLC Method through the QbD Approach for the Quantification of Honokiol and Metformin Hydrochloride – Method Validation and Pharmaceutical Applications on Oral Dosage Forms" Preprints. https://doi.org/10.20944/preprints202407.0542.v1
Abstract
For quantitative determination of honokiol (HNK) and metformin hydrochloride (M-HCl) by HPLC from formulations and from dissolution studies, a QbD approach using three factors - three levels design was implemented to optimize the chromatographic conditions. To study the impact of each variable on the peak area of both compounds and retention time of last compound eluted, the 3D response surface plots were developed. HNK and M-HCl were separated on a Thermoscientific ODS Hypersyl TM (250 x 4.6 mm, 5 μm) column mantained at 30 C, using 0.02 M acetate buffer (pH = 3) / methanol (15 / 85, v / v) as mobile phase with a flow rate of 1 mL/min. The injected volume was 20 L, and the detection wavelengths were 256 nm for HNK and 236 nm for M-HCl. The validation of proposed method showed a linearity range of 4 – 1200 μg/mL for M-HCl (r2 = 0.9992) and 1 – 300 μg/mL for HNK (r2 = 0.9998), good precision (RSD < 2% for both HNK and M-HCl, in intra- and inter-day studies) and accuracy (mean recovery = 100.09% in the range 99.80 – 100.43% for M-HCl and mean recovery = 100.12% in the range 99.70 – 100.38% for HNK). The environmentally friendly nature of the method was confirmed by the evaluation of the method’s greenness. The proposed method was applied for the determination of HNK and M-HCl from oral dosage forms and in dissolution studies.
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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