Budesonide is a glucocortico steroid used for the treatment of nasal polyposis, asthma and Crohn’s disease. A stability indicating RP-HPLC method has been developed and validated for the quantification of Budesonide in pharmaceutical dosage forms in presence of an internal standard, Etoricoxib. Mobile phase including a mixture of formic acid: acetonitrile: methanol (25: 10: 65) was chosen for the chromatographic study with flow rate 1.0 ml/min. The PDA detection was carried at 240 nm and the elution was achieved on isocratic mode using Zorbox C18 column. Beer-Lambert’s law was obeyed over a concentration range 0.05-120 µg/ml and the linear regression equation was y = 0.0489x + 0.003 with correlation coefficient 0.9997). The LOQ and LOD was found to be and 0.0393 and 0.1192 µg/ml. Stress degradation studies such as acidic hydrolysis, alkaline hydrolysis, oxidation and thermal degradation were performed. The method was validated for the parameters linearity, precision, accuracy, robustness as per ICH guidelines and the proposed stability indicating liquid chromatographic method was found to be simple, accurate, precise and robust and can be applied for the assay Budesonide formulations.
Cite this article:
Bandaru Sai Pavan Kumar, Mukthinuthalapati Mathrusri Annapurna. Development and validation of a new stability indicating RP-HPLC method for the quantification of Budesonide in pharmaceutical dosage forms in presence of an internal standard. Research Journal of Pharmacy and Technology. 2022; 15(5):2103-9. doi: 10.52711/0974-360X.2022.00349
Bandaru Sai Pavan Kumar, Mukthinuthalapati Mathrusri Annapurna. Development and validation of a new stability indicating RP-HPLC method for the quantification of Budesonide in pharmaceutical dosage forms in presence of an internal standard. Research Journal of Pharmacy and Technology. 2022; 15(5):2103-9. doi: 10.52711/0974-360X.2022.00349 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2022-15-5-31
1. Ellul-Micallef R, Hansson E, Johansson SA: Budesonide: a new corticosteroid in bronchial asthma. Eur J Respir Dis. 1980; 61(3):167-173.
2. Stanaland BE. Once-daily Budesonide aqueous nasal spray for allergic rhinitis: A review. Clinical Therapeutics. 2004; 26 (4): 473-492.
3. Silverman J, Otley A. Budesonide in the treatment of inflammatory bowel disease. Expert Rev Clin Immunol. 2011; 7 (4): 419-428.
4. Raveendra Babu Gudimitla, Lakshmana Rao Atmakuri, Venkateswara Rao Jangala. A novel method for the estimation of Budesonide in human plasma by using LC-MSMS. Der Pharma Chemica, 2018: 10(4): 181-185.
5. Sai Sheela A, Mathrusri Annapurna M and Spandana Yasaswini R. New validated stability indicating RP-UFLC method for the determination of Budesonide. Research Journal of Pharmacy and Technology. 2020; 13(6): 2819-2824.
6. Demurtas A, Pescina S, Nicoli S, Santi P, Ribeiro de Araujo D, Padula C. Validation of a HPLC-UV method for the quantification of budesonide in skin layers. J Chromatogr B Analyt Technol Biomed Life Sci. 2021; 1164: 122512.
7. Yamani NS and Mathrusri Annapurna M. New Stability indicating RP-HPLC method for the estimation of Budesonide in API and pharmaceutical dosage forms. Asian Journal of Pharmaceutics. 2022; 15(04): 498-503.
8. Gupta M, Bhargava HN. Development and validation of a high-performance liquid chromatographic method for the analysis of Budesonide. Journal of Pharmaceutical and Biomedical Analysis. 2006; 40(2): 423-428.
9. Roth G, Wikby A, Nilsson L, Thalén A. High-performance liquid chromatographic determination of epimers, impurities, and content of the glucocorticoid budesonide and preparation of primary standard. J Pharm Sci. 1980; 69(7): 766-770.
10. Shuguang Hou, Michael Hindle, Peter RByron. A stability-indicating HPLC assay method for Budesonide. J Pharm Biomed Anal. 2001; 24(3): 371-380.
11. Faouzi MA, Dine T, Luyckx M, Brunet C, Gressier B, Cazin M, Wallaert B, Cazin JC. High-performance liquid chromatographic method for the determination of budesonide in bronchoalveolar lavage of asthmatic patients. J Chromatogr B Biomed Appl. 1995; 664(2): 463-467.
12. Sonali RN and Amrita NB. Development of a validated specific HPLC method for Budesonide and characterization of its alkali degradation product. Canadian Journal of Analytical Sciences and Spectroscopy. 2008; 53(3): 113-122.
13. ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization (2005).
14. ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization (2003).