DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ACLIDINIUM BROMIDE AND FORMOTEROL FUMARATE IN BULK AND INHALER FORMULATION

A. JAYA LAKSHMI; K. ABHISHEK; Y. LEELA PRIYANKA; P. V. BALAJI; N. ASHRITHA

doi:10.22159/ijcpr.2022v14i5.1973

Authors

A. JAYA LAKSHMI School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University Kakinada, Kakinada-533003, Andhra Pradesh, India
K. ABHISHEK School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University Kakinada, Kakinada-533003, Andhra Pradesh, India
Y. LEELA PRIYANKA School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University Kakinada, Kakinada-533003, Andhra Pradesh, India
P. V. BALAJI School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University Kakinada, Kakinada-533003, Andhra Pradesh, India
N. ASHRITHA School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University Kakinada, Kakinada-533003, Andhra Pradesh, India

DOI:

https://doi.org/10.22159/ijcpr.2022v14i5.1973

Keywords:

Reverse phase-high-performance liquid chromatography, Validation, Formoterol fumarate, Aclidinium bromide

Abstract

Objective: To develop a simple, accurate, precise, rapid and sensitive method for the simultaneous estimation of Formoterol fumarate and Aclidinium bromide in pharmaceutical dosage form.

Methods: The chromatogram was run through Ascentis C₁₈150 x 4.6 mm, 5µ. Mobile phase containing Water: Acetonitrile taken in the ratio 60:40 was pumped through the column at a flow rate of 1.0 ml/min. The temperature was maintained at 30 °C. The optimized wavelength selected was 220 nm.

Results: The retention times of Formoterol fumarate and Aclidinium bromide were found to be 2.953 min and 2.364 min. %RSD of the Aclidinium bromide and Formoterol fumarate was found to be 0.6 and 0.9, respectively. %Recovery was obtained as 99.81 % and 100.20% for Aclidinium bromide and Formoterol fumarate, respectively. LOD, LOQ values obtained from the Signal-to-noise ratio of Aclidinium bromide and Formoterol fumarate were 0.84 µg/ml, 2.56 µg/ml and 0.01 µg/ml, 0.03µg/ml respectively. Regression equation of Formoterol fumarate is y =9023x+268.67, and y = 4661.2x+1941.9 of Aclidinium bromide. Retention times were decreased and that run time was decreased, so the method developed was simple, rapid, sensitive and economical that can be adopted in regular quality control tests in Industries.

Conclusion: Developed and Validated Formoterol fumarate and Aclidinium bromide in pharmaceutical dosage form by using RP-HPLC method.

Downloads

Download data is not yet available.

References

Drug bank Online. Database for drugs and drug target info [https://go.drugbank.com], Aclidinium Bromide. Available from: https://www.drugbank.ca/salts/DBSALT001371 [Last accessed on 29 Jul 2022]

Aclidinium bromide. Available from: https://www.webmd.com/drugs/2/drug-162176/aclidinium-bromide-inhalation/details.

Drug bank Online. Database for drugs and drug target info [https://go.drugbank.com/], Formoterol Fumarate; Available from: https://www.drugbank.ca/salts/DBSALT000003 [Last accessed on 29 Jul 2022]

Formoterol fumarate. Available from: https://www.webmd.com/drugs/2/drug-20787-5304/formoterol-fumarate-inhalation/formoterol-powder-in-capsule-oral-inhalation/details.

Ghulam A. Shabir HPLC method development and validation for pharmaceutical analysis. Pharmtech. 2004 Mar 1;16(3).

Vidushi Y, Bharkatiya Meenakshi A. Review on HPLC method development AND validation. RJLBPCS. 2017;2(6):166-78.

Gowda R, Padmakar A. Sathe simultaneous rp-hplc method for determination of impurities in formoterol fumarate and aclidinium bromide in pharmaceutical dosage forms. Available from: http://www.ijcpa. [Last accessed on 03 Jun 2016]

Srinivasu K, Venkateswara Rao J. Simultaneous RP-HPLC method for the estimation of formoterol fumarate and tiotropium bromide in pharmaceutical dosage forms. Asian J Chem. 2010 May;22(5):3943-8.

Rakshit Kanubhai Trived DS, Chendake MC, Rapid PA. Stability-indicating RP-HPLC method for the simultaneous determination of formoterol fumarate, tiotropium bromide, and ciclesonide in a pulmonary drug product. Sci Pharm. 2012;80:591-603.

Akapo SO, Asif M. Validation of a RP-HPLC method for the assay of formoterol and its related substances in formoterol fumarate dihydrate drug substance. J Pharm Biomed Anal. 2003 Dec 5;33(5):935-45. doi: 10.1016/s0731-7085(03)00425-4, PMID 14656584.

International Conference on Harmonization on Validation of Analytical Procedures: Text and Methodology; 2005.

International Conference on Harmonization. Stability guidelines. Vol. Q1; 2019. doi: 10.22214/ijraset.2019.12163

Snyder LR, Kirkland JJ, Joseph L. Glajch quantitation (Including trace analysis). 2nd ed. Wiley India Pvt. Ltd; 1997. p. 645-9.

Trivikram Rawat PIP. Forced degradation studies for drug substances and drug products-scientific and regulatory considerations. J Pharm Sci Res. 2015;7(5):238-41.

Charde MS, Kumar J, Welankiwar AS, Chakole RD. Development of forced degradation studies of drugs. Int J Adv Pharmaceutics. 2013;2(3):34-9.

Hokanson GC. A life cycle approach to the validation of analytical methods during pharmaceutical product development. Part 1: The initial validation process. Pharm Technol. 1994:92-100.