Development and Validation of HPLC Method for Identification of Ramipril in Printed Tablets and Filaments

Introduction. 3D printing has shown its usefulness as a drug manufacturing technology over the past decade. However, the lack of regulated methods for quality control of finished printed drugs imposes a limitation on the widespread use of 3D printing methods in pharmaceutical practice. Thus, the dev...

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Main Authors: V. V. Tihonova, O. A. Terenteva, K. A. Gusev, E. V. Flisyuk, D. N. Maimistov
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2022-11-01
Series:Разработка и регистрация лекарственных средств
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Online Access:https://www.pharmjournal.ru/jour/article/view/1379
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author V. V. Tihonova
O. A. Terenteva
K. A. Gusev
E. V. Flisyuk
D. N. Maimistov
author_facet V. V. Tihonova
O. A. Terenteva
K. A. Gusev
E. V. Flisyuk
D. N. Maimistov
author_sort V. V. Tihonova
collection DOAJ
description Introduction. 3D printing has shown its usefulness as a drug manufacturing technology over the past decade. However, the lack of regulated methods for quality control of finished printed drugs imposes a limitation on the widespread use of 3D printing methods in pharmaceutical practice. Thus, the development of methods for the analysis of printed dosage forms is of interest in pharmaceutical development.Aim. To develop a specific method for the determination of ramipril in filaments and printlets by HPLC.Materials and methods. Substance: ramipril. Excipients: Kollidon® VA 64, Kollidon® CL-F, PEG-1500, sodium carbonate anhydrous, Poloxamer-188, sodium stearyl fumarate. Reagents: hydrochloric acid, acetonitrile for ultra-HPLC, sodium octanesulfonate for HPLC, orthophosphoric acid 85 %, sodium perchlorate analytical grade, triethylamine. Standard: ramipril USP (No 1598303).Results and discussion. A special HPLC method in accordance with an ion-pair reagent (sodium octanesulfonate) for the determination of ramipril in the composition of filaments and printets was proposed.Conclusion. The developed chromatographic method should be adapted for ramipril release determination. This method can be used to quantify ramipril in further studies.
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publishDate 2022-11-01
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series Разработка и регистрация лекарственных средств
spelling doaj-art-53fe3bfbf68b43669d20eb0919faa11a2025-08-20T03:19:32ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492022-11-0111420921510.33380/2305-2066-2022-11-4-209-2151038Development and Validation of HPLC Method for Identification of Ramipril in Printed Tablets and FilamentsV. V. Tihonova0O. A. Terenteva1K. A. Gusev2E. V. Flisyuk3D. N. Maimistov4Saint-Petersburg State Chemical-Pharmaceutical UniversitySaint-Petersburg State Chemical-Pharmaceutical UniversitySaint-Petersburg State Chemical-Pharmaceutical UniversitySaint-Petersburg State Chemical-Pharmaceutical UniversitySaint-Petersburg State Chemical-Pharmaceutical UniversityIntroduction. 3D printing has shown its usefulness as a drug manufacturing technology over the past decade. However, the lack of regulated methods for quality control of finished printed drugs imposes a limitation on the widespread use of 3D printing methods in pharmaceutical practice. Thus, the development of methods for the analysis of printed dosage forms is of interest in pharmaceutical development.Aim. To develop a specific method for the determination of ramipril in filaments and printlets by HPLC.Materials and methods. Substance: ramipril. Excipients: Kollidon® VA 64, Kollidon® CL-F, PEG-1500, sodium carbonate anhydrous, Poloxamer-188, sodium stearyl fumarate. Reagents: hydrochloric acid, acetonitrile for ultra-HPLC, sodium octanesulfonate for HPLC, orthophosphoric acid 85 %, sodium perchlorate analytical grade, triethylamine. Standard: ramipril USP (No 1598303).Results and discussion. A special HPLC method in accordance with an ion-pair reagent (sodium octanesulfonate) for the determination of ramipril in the composition of filaments and printets was proposed.Conclusion. The developed chromatographic method should be adapted for ramipril release determination. This method can be used to quantify ramipril in further studies.https://www.pharmjournal.ru/jour/article/view/1379specificityramiprilhplcprinted dosage forms3d printing
spellingShingle V. V. Tihonova
O. A. Terenteva
K. A. Gusev
E. V. Flisyuk
D. N. Maimistov
Development and Validation of HPLC Method for Identification of Ramipril in Printed Tablets and Filaments
Разработка и регистрация лекарственных средств
specificity
ramipril
hplc
printed dosage forms
3d printing
title Development and Validation of HPLC Method for Identification of Ramipril in Printed Tablets and Filaments
title_full Development and Validation of HPLC Method for Identification of Ramipril in Printed Tablets and Filaments
title_fullStr Development and Validation of HPLC Method for Identification of Ramipril in Printed Tablets and Filaments
title_full_unstemmed Development and Validation of HPLC Method for Identification of Ramipril in Printed Tablets and Filaments
title_short Development and Validation of HPLC Method for Identification of Ramipril in Printed Tablets and Filaments
title_sort development and validation of hplc method for identification of ramipril in printed tablets and filaments
topic specificity
ramipril
hplc
printed dosage forms
3d printing
url https://www.pharmjournal.ru/jour/article/view/1379
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AT evflisyuk developmentandvalidationofhplcmethodforidentificationoframiprilinprintedtabletsandfilaments
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