Sensitive and validated UPLC-MS/MS method for the identification and characterization of forced degradation products for felodipine

• Autorzy: Babu M. Ajay , Kumar J.V. Shanmukh , Naresh N. , Mankumare Sharad D.

Identyfikatory

DOI

10.1556/1326.2022.01106

• Języki publikacji: EN

Abstrakty

EN

A rapid, stability indicating reverse phase liquid chromatographic method was developed for the determination of purity of Felodipine in active pharmaceutical substance form in the presence of its impurity and its degradation products. To develop the method which is also compatible to liquid chromatographic mass spectroscopic technique. The developed method is also used to determine the assay of Felodipine in bulk drug form. The drug is subjected to various stress conditions like acidic, basic, oxidation, UV light and thermal conditions. Considerable degradation was observed during base hydrolysis. Two degradation products were identified. The Waters Acquity UPLC BEH C18, 2.1 3 100 mm, 1.7 μm Column was used to achieve chromatographic separation. The gradient conditions, diluent and injection volume were optimized to achieve the acceptable resolution between impurities and its degradation products from Felodipine and to get good peak shapes. The masses were determined for main compound and its identified degradation products. Further, the characterization studies for main compound and its degradation products were performed using LCMSMS Q-TOF.

Słowa kluczowe

EN

felodipine; MSMS; stability indicating; degradation products; characterization studiem

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2024
• Tom: Vol. 36, no. 2
• Strony: 114--124
• Opis fizyczny: Bibliogr. 24 poz., rys., wytkr.

Twórcy

autor

Babu M. Ajay

• Department of Engineering Chemistry, College of Engineering, Koneru Lakshmaiah Education Foundation, Vaddeswaram, AP, India
• USP India Private Limited, IKP Knowledge Park, Hyderabad-500101, India

• https://orcid.org/0000-0002-3262-7911

autor

Kumar J.V. Shanmukh

• Department of Engineering Chemistry, College of Engineering, Koneru Lakshmaiah Education Foundation, Vaddeswaram, AP, India

• https://orcid.org/0000-0002-5725-690X

autor

Naresh N.

• USP India Private Limited, IKP Knowledge Park, Hyderabad-500101, India

autor

Mankumare Sharad D.

• USP India Private Limited, IKP Knowledge Park, Hyderabad-500101, India

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