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.

Autor: Reddy Saddala MP; Department of Chemistry, School of Science, GITAM (Deemed to Be University) Hyderabad, Sangareddy, India., Konduru N; Analytical Research and Development, Zhuhai Resproly Pharmaceutical Technology Co., Ltd, Zhuhai City, China., Gundla R; Department of Chemistry, School of Science, GITAM (Deemed to Be University) Hyderabad, Sangareddy, India., Kowtharapu LP; Analytical Development, WUXI STA (Wuxi app Tec Company) Pharmaceutical Co., Ltd, Wuxi, China.

Publikováno v: Biomedical chromatography : BMC [Biomed Chromatogr] 2022 Dec; Vol. 36 (12), pp. e5486. Date of Electronic Publication: 2022 Sep 19.

Determination of Valbenazine related substances by liquid chromatography method complying with the current regulatory guidelines. Method robustness evaluation by Design of Experiments software.

Autor: Deshmukh, Balasaheb R.¹ (AUTHOR), Akshinthala, Parameswari² (AUTHOR), Katari, Naresh Kumar³ (AUTHOR), Deshpande, Girish K.¹ (AUTHOR), Kowtharapu, Leela Prasad³ (AUTHOR), Battula, Sreenivas Rao¹ (AUTHOR) sbattula2@gitam.edu, Gundla, Rambabu³ (AUTHOR) rgundla@gitam.edu

Publikováno v: Separation Science Plus. Sep2023, Vol. 6 Issue 9, p1-11. 11p.