DEVELOPMENT AND VALIDATION OF UV-SPECTROSCOPIC METHOD FOR ESTIMATION OF IPRATROPIUM BROMIDE IN API AND IN PHARMACEUTICAL DOSAGE FORM
Keywords:Ipratropium bromide, UV Spectrophotometer, Methanol, Validation
Objective: To developed and validated UV spectrophotometric method for the estimation of ipratropium bromide in API and pharmaceutical formulation.
Methods: Methanol is used as a solvent and the absorbance of the drug was measured at absorbance’s maxima of ipratropium bromide max is 214 nm.
Results: Maximum absorbance obtained in 214 nm. Calibration curve plotted in concentration range 20-120 µm/ml exhibit the linearity relationship with line equation y=.0.0091x+0.1503 The Accuracy was found to be 99.7-100.2%, the precision %RSD= 0.08613-0.2668, and the LOD and LOQ is 6.33, 19.19. The method was found to comply all the validation parameters as per the ICH guideline indicating the sensitivity of the method analyte.
Conclusion: This method is used as satisfactory for the routine analysis of ipratropium bromide in API and pharmaceutical dosage forms.
2. https://www.Drugbanh.ca/drugs/DB00332 [Last accessed on 10 May 2020]
3. P Nagarju, SCHVSS Appaji. Development and validation of novel RP-HPLC method for simultaneous estimation of levosalbutamol and Ipratropium bromide in pharmaceutical dosage form. Int J Res Pharm Chem 2014;4:635.
4. Gummadi Sowjanya, D Gowri Sankar, JVLN Seshagiri Rao. Development and validation of a new RP-HPLC method for the simultaneous determination of of albuterol sulphate and Ipratropium Bromide in nasal inhalation. Int Res J Pharm Step 2018;9:63-70.
5. K Kranthi Kiran. A new analytical method development and validation for the simultaneous estimation of albuterol and Ipratropium bromide using RP-HPLC. Int J Pharma Investigation Res 2017;4:72-95.
6. ICH, Q2 (R1) Validation of analytical procedures: text methodology, international conference on harmonization; 1196.
7. Ravi Vankudoth, RP Pulla, B Umasankar, G Saisneha, S Chawan, A Aparna. RP-HPLC method for simultaneous estimation of Ipratropium bromide and levolbutamol in pharmaceutical metered-dose inhalers. IJRPC 2013;3:2231-781.
8. GB Kasawar, M Faooqui. Development and validation of stability indicating RP-HPLC for the simultaneous determination of related substance of Albuterol sulphate and Ipratropium bromide in nasal solution. J Pharm Biomed Anal 2010;52:19-20.
9. A Rasheed, O Ahmed. Analytical separation and characterization of degradation product and the development and validation of stability indicating method for the estimation of impurities in Ipratropium bromide respules formulation. Int J Appl Pharm Sci Res 2017;2:55-63.
10. SM Raj, VJ Jamakandi. Estimation of Ipratropium bromide by extraction free spectrophotometric method using sulphonapthalein dye. Int J Pharm Sci Res 2017;24:4605-12.
11. Chester C. Wood, Philip Fireman, Jay Grossman, product characteristics and pharmacokinetics of intranasal ipratropium bromide. J Allergy Clin Immunol 1995;95:1111-6.