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Drug Res (Stuttg) 2023; 73(06): 335-340
DOI: 10.1055/a-2007-1820
Original Article

HPLC-UV/VIS for Determination of Ipratropium Bromide Mixed with Salbuterol, Beclomethasone Propionate and Budesonide using Dual Wavelength-Detection Method

Guo Haihua
1   College of Biomedical and Pharmaceutical Science, Guangdong University of Technology, Higher Education Mega Center, Guangzhou, China
,
Zhang Rui
2   College of pharmacy, Sun Yet-Sen University, Higher Education Mega Center, Guangzhou, China
,
Deng Liangjun
1   College of Biomedical and Pharmaceutical Science, Guangdong University of Technology, Higher Education Mega Center, Guangzhou, China
,
Li Meng
1   College of Biomedical and Pharmaceutical Science, Guangdong University of Technology, Higher Education Mega Center, Guangzhou, China
,
Li Sha
1   College of Biomedical and Pharmaceutical Science, Guangdong University of Technology, Higher Education Mega Center, Guangzhou, China
,
Zhao Suqing
1   College of Biomedical and Pharmaceutical Science, Guangdong University of Technology, Higher Education Mega Center, Guangzhou, China
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Abstract

Background Inhalation preparation involves liquid or solid raw materials for delivering to lungs as aerosol or vapor. The liquid preparation for nebulizer is effective for convenient use and patient compliance and it has been extensively used in the treatment of clinical lung diseases. Clinical staff often mixes the compound ipratropium bromide with beclomethasone propionate and budesonide inhaler but reference values of inhalants for clinical use need to be established for simplifying the operation procedure. The high-performance liquid chromatography (HPLC) method of compound ipratropium bromide solution, beclomethasone propionate suspension and budesonide suspension after mixed atomization was studied.

Methods The specificity, linearity, recovery (accuracy), precision and stability of compound ipratropium bromide, beclomethasone propionate and budesonide were tested to verify the developed liquid phase method.

Results The developed liquid phase method had high specificity, linear R2≥0,999, recovery (accuracy) RSD (relative standard deviation) less than 2%, precision RSD less than 2,0%, and stability RSD less than 2,0%.

Conclusion The liquid phase methodology developed in this study can be used for the determination of compound ipratropium bromide mixed with beclomethasone propionate and budesonide. The current methodology can also be used to provide a reference for the determination of its content after mixing, and further data support for its clinical medication.

Key words

salbuterol - ipratropium bromide - beclomethasone propionate - budesonide - detection of mixture utilization - dual wavelength-detection for HPLC method


Publication History

Received: 09 November 2022

Accepted: 23 December 2022

Article published online:
03 February 2023

© 2023. Thieme. All rights reserved.

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  • References

  • 1 Commission NP. The Pharmacopoeia of the People’s Republic of China. 2015 ed.. China: China Medical Science and Technology Press; 2015
    Google Scholar
  • 2 Hickey AJ. Back to the future: inhaled drug products. Journal of pharmaceutical sciences 2013; 102: 1165-1172 DOI: 10.1002/jps.23465.
    CrossrefPubMedGoogle Scholar
  • 3 Jain H, Bairagi A, Srivastava S. et al. Recent advances in the development of microparticles for pulmonary administration. Drug Discovery Today 2020; DOI: 10.1016/j.drudis.2020.07.018.
    CrossrefPubMedGoogle Scholar
  • 4 Telko MJ, Hickey AJ. Dry powder inhaler formulation. Respiratory care 2005; 50: 1209-1227
    PubMedGoogle Scholar
  • 5 Rui Z, Haoluan Z, Xuejuan Z. et al. Preparation and prescription optimization of levobambuterol inhalation water mist Preparation and formulation optimization of R-bambuterol inhalation solution. Journal of Guangdong Pharmaceutical University 2020; 36: 322-328
    PubMedGoogle Scholar
  • 6 Hualin W, Yuzhen Z, Xinjian D. Efficacy and safety of doxofylline combined with combivent against acute exacerbation of bronchial asthma in 60 patients. Chinese Hospital Pharmacy Journal 2015; 35: 1485-1487
    PubMedGoogle Scholar
  • 7 Dalby R, Suman J. Inhalation therapy: technological milestones in asthma treatment. Advanced drug delivery reviews 2003; 55: 779-791 DOI: 10.1016/S0169-409X(03)00077-2.
    CrossrefPubMedGoogle Scholar
  • 8 Edwards DA, Ben-Jebria A, Langer R. Recent advances in pulmonary drug delivery using large, porous inhaled particles. Journal of applied physiology 1998; 85: 379-385 DOI: 10.1152/jappl.1998.85.2.379.
    CrossrefPubMedGoogle Scholar
  • 9 Brogden RN, McTavish D. Budesonide. Drugs 1992; 44: 375-407 DOI: 10.2165/00003495-199244030-00007.
    CrossrefPubMedGoogle Scholar
  • 10 Pilcer G, Amighi K. Formulation strategy and use of excipients in pulmonary drug delivery. International journal of pharmaceutics 2010; 392: 1-19 DOI: 10.1016/j.ijpharm.2010.03.017.
    CrossrefPubMedGoogle Scholar
  • 11 Simons F. Canadian Beclomethasone Dipropionate-Salmeterol Xinafoate Study Group. A comparison of beclomethasone, salmeterol, and placebo in children with asthma. N Engl J Med 1997; 337: 1659-1665 DOI: 10.1056/NEJM199712043372304.
    CrossrefPubMedGoogle Scholar
  • 12 Xiao Ling YJ, Liu WE. et al. Budesonide combined with compound ipratropium bromide nebulized inhalation in the treatment of children with acute asthmatic bronchitis. Western Medicine 2017; 29: 1731-1732
    PubMedGoogle Scholar
  • 13 Hongquan W. Beclomethasone dipropionate suspension plus ipratropium bromide aerosol effect on symptoms of children with bronchiolitis. Heilongjiang Medicine and Pharmacy 2019; 42: 136-137
    PubMedGoogle Scholar
  • 14 Zhang R, Hu J, Deng L. et al. Aerosol Characteristics and Physico-Chemical Compatibility of Combivent®(Containing Salbutamol and Ipratropium Bromide) Mixed with Three Other Inhalants: Budesonide, Beclomethasone or N-Acetylcysteine. Pharmaceutics 2020; 12: 78 DOI: 10.3390/pharmaceutics12010078.
    CrossrefPubMedGoogle Scholar
  • 15 Power M, Fell G, Wright M. Principles for high-quality, high-value testing. Evidence Based Medicine 2013; 18: 5-10 DOI: 10.1136/eb-2012-100645.. DOI: 10.1136/eb-2012-100645
    CrossrefPubMedGoogle Scholar
  • 16 Kroll MH, Emancipator K. A theoretical evaluation of linearity. Clinical chemistry 1993; 39: 405-413
    CrossrefPubMedGoogle Scholar
  • 17 Lugos MD, Damulak OD, Perikala V. et al. Assay linearity and spike-recovery assessment in optimization protocol for the analysis of serum cytokines by sandwich ELISA platform. Am J Biomed Sci 2019; 3(2): 178–183
    PubMedGoogle Scholar
  • 18 Chesher D. Evaluating assay precision. The Clinical biochemist Reviews. 2008 29. Suppl 1):S23-6. Epub 2008/10/15. PubMed PMID: 18852851; PubMed Central PMCID: PMCPmc2556577
    PubMedGoogle Scholar