Author(s):
Dipak Chandrakant Kulkarni, Anima Sunil Dadhich, Mukthinuthalapati Mathrusri Annapurna
Email(s):
mmukthin@gitam.edu
DOI:
10.52711/0974-360X.2023.00629 
Address:
Dipak Chandrakant Kulkarni1, Anima Sunil Dadhich1, Mukthinuthalapati Mathrusri Annapurna2*
1Department of Chemistry, GITAM School of Science, GITAM (Deemed to be University) Visakhapatnam, India-530045.
2GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India-530045.
*Corresponding Author
Published In:
Volume - 16,
Issue - 8,
Year - 2023
ABSTRACT:
Bumetanide is a diuretic used to reduce edema caused by the conditions such as heart failure, kidney disease, and liver disease. A new stability indicating isocratic LC-APCI-MS and RP-HPLC methods have been developed and validated for the estimation of Bumetanide as per ICH guidelines. Thermo scientific-TSQ Quantis with Vanquish HPLC coupled with MS was used for the present study. Simpack C18 column was used for chromatographic resolution and a triple quadrupole mass spectrometer with atmospheric pressure chemical ionization (APCI) source, running in the positive mode (as well as negative mode) was used for detection. A mixture of 0.1% Formic acid: Acetonitrile was used as mobile phase on gradient mode and Acetonitrile was used as diluent. A wide linearity concentration range 5.0-200 µg/ml was shown by the proposed method. The proposed methods are simple, precise, accurate and used to quantify the marketed formulations of Bumetanide. Stress degradation studies were performed and the method is found to be selective and specific.
Cite this article:
Dipak Chandrakant Kulkarni, Anima Sunil Dadhich, Mukthinuthalapati Mathrusri Annapurna. Method development and validation of a new stability indicating HPLC and LC-APCI-MS methods for the determination of Bumetanide. Research Journal of Pharmacy and Technology. 2023; 16(8):3809-7. doi: 10.52711/0974-360X.2023.00629
Cite(Electronic):
Dipak Chandrakant Kulkarni, Anima Sunil Dadhich, Mukthinuthalapati Mathrusri Annapurna. Method development and validation of a new stability indicating HPLC and LC-APCI-MS methods for the determination of Bumetanide. Research Journal of Pharmacy and Technology. 2023; 16(8):3809-7. doi: 10.52711/0974-360X.2023.00629 Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-8-49
REFERENCES:
1. Halstenson CE and Matzke GR. Bumetanide: A new loop diuretic (Bumex, Roche Laboratories). Drug Intell Clin Pharm. 1983; 17(11): 786-797.
2. Sprengers JJ, Van Andel DM, Zuithoff NP, Keijzer-Veen MG, Schulp AJ, Scheepers FE, et al. bumetanide for core symptoms of autism spectrum disorder (bambi): a single center, double-blinded, participant-randomized, placebo-controlled, phase-2 superiority trial. Journal of the American Academy of Child and Adolescent Psychiatry. 2020; 60(7): 865-876.
3. Zhang L, Huang CC, Dai Y, Luo Q, Ji Y, Wang K, et al. Symptom improvement in children with autism spectrum disorder following Bumetanide administration is associated with decreased GABA/glutamate ratios. Translational Psychiatry. 2020; 10(1): 9. Erratum in: Transl Psychiatry. 2020 Feb 12; 10(1): 63.
4. Dinesh SP, Naveen Sharma, Mukesh Patel C, Bhavin Patel N, Pranav Shrivastav S, Mallika Sanyal. Application of a rapid and sensitive liquid chromatography-tandem mass spectrometry LC-MS method for determination of Bumetanide in human plasma for a bioequivalence study. Journal of Pharmaceutical and Biomedical Analysis. 2012; 66(7): 365-370.
5. Li Y, Cleary R, Kellogg M, Soul JS, Berry GT, Jensen FE. Sensitive isotope dilution liquid chromatography/tandem mass spectrometry method for quantitative analysis of Bumetanide in serum and brain tissue. J Chromatogr B Analyt Technol Biomed Life Sci. 2011; 879(13-14): 998-1002.
6. Mohan Kumar. Rao Janhavi R, Yadav Savita S, Sathiyanarayanan L and Vikas. Development and validation of a stability-indicating HPTLC method for analysis of Bumetanide in the bulk drug and tablet dosage form. Research Journal of Pharmacy and Technology. 2010; 3(1): 239-243.
7. Petr Solich, Christoforos K Polydorou, Michael A Koupparis, Constantinos E Efstathiou. Automated flow injection fluorimetric determination and dissolution studies of Bumetanide in pharmaceuticals. Analytica Chimica Acta. 2001; 438(1-2): 131-136.
8. Chaitanya B and Raja Sundararajan. Method development, validation and stability studies for determination of Bumetanide in bulk and pharmaceutical dosage form by RP-UPLC. International Journal of Pharmacy and Pharmaceutical Sciences. 2018; 10(3): 35-42.
9. Wells TG, Hendry IR and Kearns GL. Measurement of Bumetanide in plasma and urine by High-performance liquid chromatography HPLC and application to Bumetanide disposition. Journal of chromatography. 1991; 570(1): 235-242.
10. David E. Smith. High-performance liquid chromatographic assay for Bumetanide in plasma and urine. Journal of Pharmaceutical Sciences. 1982; 71(5): 520-523.
11. Rao JR, Mohan Kumar, Yadav SS. Stability indicating RP- HPLC method for Bumetanide in bulk drug and tablet formulation. Asian Journal of Research in Chemistry. 2009; 2(3): 266-269.
12. HUANG Qin, HU Jianying, FENG Xiaozhen. HPLC determination of the dissolution of Bumetanide tablets. Chinese Journal of Pharmaceutical Analysis. 2007; 27(8): 1285-1287.
13. Legorburu MJ, Alonso RM, Jiménez RM, and Ortiz E. Quantitative determination of the loop diuretic Bumetanide in urine and pharmaceuticals by high-performance liquid chromatography (HPLC) with amperometric detection. Journal of Chromatographic Science. 2001; 39(10): 425-430.
14. Mathrusri Annapurna M, Spandana Yasaswini R and Sai Sheela A. New stability indicating RP-UFLC method for the determination of Bumetanide - A potent diuretic. Acta Scientific Pharmaceutical Sciences. 2019; 3(8): 84-90.
15. Mathrusri Annapurna M, Sai Sheela A and Spandana Yasaswini R. New first derivative spectrophotometric methods for the estimation of Bumetanide in tablet dosage forms. Research Journal of Pharmacy and Technology. 2019; 12(10): 4790-4794.
16. Mathrusri Annapurna M, Raghu Raj N and Mounica Pratyusha S. New spectrophotometric methods for the quantification of Bumetanide tablets. Acta Scientific Pharmaceutical Sciences. 2019; 3(8): 91-95.
17. ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization, 2005.
18. ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization, 2003.