DEVELOPMENT AND VALIDATION OF LC-MS/MS METHOD FOR SIMULTANEOUS ESTIMATION OF AZELNIDIPINE AND TELMISARTAN IN TABLET AND CHARACTERIZATION OF DEGRADANT BY LC-MS/MS

Registration ID: IJNRD_196838

Published ID: IJNRD2305673

DOI: Click Here to Get

Hiral j Prajapati , Mr. Dhaval Patel , Dr. Chaitanya bhatt , Mr. Nishith Patel , Dr. Vanita Marvaniya

Azelnidipine, Telmisartan, LC-MS/MS method, Validation, ICH Q2 (R1) guidelines.

The objective of this study was to explore the degradation behavior of Azelnidipine and Telmisartan under acidic, basic, oxidative, photolytic and thermal stress conditions as per prescribed International Conference on Harmonization (ICH) guidelines. Azelnidipine was found to be liable under acidic and oxidative stress conditions, whereas it was stable under basic, photolytic and thermal stress conditions. Similarly, Telmisartan was found to be liable under acidic and oxidative stress conditions, whereas it was stable under basic, photolytic and thermal stress conditions. A total of two degradation products (DPs) were characterized for azelnidipine and two degradation products (DPs) were characterized for Telmisartan, and their chromatographic separation was accomplished on Hypersil, BDS, C18, (150mm x 4.6mm, 5µm) column using a mobile phase consisting buffer (pH-5) : methanol in isocratic elution mode. The ion transitions were quantified in positive mode with MRM transition of 583.300→496.200 Da for Azelnidipine and 515.100→499.500 Da for Telmisartan. All the stressed sample were subjected to ESI-MS/MS and LCMS/MS analysis. Azelnidipine and Telmisartan and its degradation products were characterized based on MRM scan mode and fragmentation patterns were obtained from ESI-MS/MS spectra. Structural elucidation of DPs of Azelnidipine and Telmisartan was achieved by comparing their fragmentation patterns with that of Azelnidipine and Telmisartan. The developed method has been validated for specificity, linearity, accuracy, precision and robustness as per ICH guideline. The method provided good linearity over the range of 0.4-1.2 μg/ml for Azelnidipine and 2.0-6.0 μg/ml for Telmisartan with short run time of 10 min. The proposed method was successfully applied for the estimation of Azelnidipine and Telmisartan in its pharmaceutical dosage form. The LC-MS/MS method were found to be simple, accurate, robust and reproducible. The assay can can be successfully applied for routine QC analysis.

Published Paper   E-Certificate

Hiral j Prajapati , Mr. Dhaval Patel, Dr. Chaitanya bhatt, Mr. Nishith Patel , & Dr. Vanita Marvaniya (May-2023). DEVELOPMENT AND VALIDATION OF LC-MS/MS METHOD FOR SIMULTANEOUS ESTIMATION OF AZELNIDIPINE AND TELMISARTAN IN TABLET AND CHARACTERIZATION OF DEGRADANT BY LC-MS/MS. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 8(5), g580-g585. https://ijnrd.org/papers/IJNRD2305673.pdf

Volume 8 Issue 5, May-2023

Pages : g580-g585

Paper Reg. ID: IJNRD_196838

Published Paper Id: IJNRD2305673

Downloads: 000121991

Research Area: Pharmacy

Country: Ahmedabad , Gujarat , India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2305673.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2305673

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

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