Stability‐indicating reversed‐phase‐HPLC method development and validation for sacubitril/valsartan complex in the presence of impurities and degradation products: Robustness by quality‐by‐design approach-Reference-Cited by-同舟云学术

Stability‐indicating reversed‐phase‐HPLC method development and validation for sacubitril/valsartan complex in the presence of impurities and degradation products: Robustness by quality‐by‐design approach

Published:2021-10 Issue:1 Volume:36 Page:
ISSN:0269-3879
Container-title:Biomedical Chromatography
language:en
Short-container-title:Biomedical Chromatography

Author:

Subramanian Velusamy B.¹,Katari Naresh Kumar¹^ORCID,Ponnam Vijetha²,Konduru Naresh³^ORCID,Dongala Thirupathi⁴^ORCID,Marisetti Vishnu M.⁵,Vyas Govind⁶

Affiliation:

1. Department of Chemistry, School of Science GITAM (deemed to be University) Hyderabad Rudraram, Sangareddy Telangana India

2. Department of Chemical Engineering, Vignan's Foundation for Science Technology and Research University Guntur India

3. Analytical Research and Development YunNan Longjin Careyou Pharmaceutical Co., Ltd. Kunming China

4. Quality Control Aurex Laboratories LLC East Windsor New Jersey USA

5. Analytical Research and Development ScieGen Pharmaceuticals Inc. New York USA

6. R&D and Regulatory Compliance Invahealth Inc. Cranbury New Jersey USA

Publisher

Wiley

Subject

Clinical Biochemistry,Drug Discovery,Pharmacology,Molecular Biology,General Medicine,Biochemistry,Analytical Chemistry

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/bmc.5240

Reference19 articles.

1. Experimental Design Approach in HPLC Method Development: Application for the Simultaneous Determination of Sacubitril and Valsartan in Presence of Their Impurities and Investigation of Degradation Kinetics

2. Valsartan: Preclinical and Clinical Profile of an Antihypertensive Angiotensin-II Antagonist

3. Quality by Design (QbD): A Practical Experimental Design Approach by Blocking and Varying Certain Factors of a Stability-Indicating HPLC Method for Simultaneous Determination of Omeprazole and Ketoprofen

4. A new way of method establishment and validation of related substance of sacubitril and valsartan by RP‐HPLC and its forced degradation study was characterized by LCMS;Gopi Raju T.;Journal of Pharmaceutical Sciences and Research,2019

5. ICH Q2A. (1994).Validation of analytical procedure: Methodology International Conference on Harmonization Geneva October 1994.

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