Development and validation of novel RP‐HPLC method for midostaurin determination using analytical quality by design approach from regulatory perspective and determination of major degradation compounds of midostaurin using LC

Development and validation of novel RP‐HPLC method for midostaurin determination using analytical quality by design approach from regulatory perspective and determination of major degradation compounds of midostaurin using LC–MS

Published:2022-09-19 Issue:12 Volume:36 Page:
ISSN:0269-3879
Container-title:Biomedical Chromatography
language:en
Short-container-title:Biomedical Chromatography

Author:

Reddy Saddala Madhu Prakash¹,Konduru Naresh²^ORCID,Gundla Rambabu¹^ORCID,Kowtharapu Leela Prasad³^ORCID

Affiliation:

1. Department of Chemistry, School of Science GITAM (Deemed to Be University) Hyderabad Sangareddy India

2. Analytical Research and Development Zhuhai Resproly Pharmaceutical Technology Co., Ltd Zhuhai City China

3. Analytical Development WUXI STA (Wuxi app Tec Company) Pharmaceutical Co., Ltd Wuxi China

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.5486

Reference20 articles.

1. Development and Validation of Midostaurin Assay by RP-HPLC Method

2. Liquid chromatography–tandem mass spectrometry assay for therapeutic drug monitoring of the tyrosine kinase inhibitor, midostaurin, in plasma from patients with advanced systemic mastocytosis

3. Development and Validation of a Sensitive Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) Assay for the Simultaneous Quantification of Midostaurin (PKC412) and Its Two Major Metabolites: A Suitable Tool for the Monitoring of the Drug in Patients Suffering From Advanced Systemic Mastocytosis

4. A Novel RP-HPLC-DAD Method Development for Anti-Malarial and COVID-19 Hydroxy Chloroquine Sulfate Tablets and Profiling of In-Vitro Dissolution in Multimedia.

5. Development and Validation of Rapid RP-HPLC Method for determination of Deferasirox in Bulk and Tablet Dosage Forms

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