Development and Validation of RP-HPLC Method for Analysis of Aclidinium Bromide and Formoterol Fumarate in Pharmaceuticals

Devadasu, Ch.; Bharani, None

doi:10.52711/2231-5675.2021.00012

AJPA

2021

DOI: 10.52711/2231-5675.2021.00012

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Development and Validation of RP-HPLC Method for Analysis of Aclidinium Bromide and Formoterol Fumarate in Pharmaceuticals

Ch. Devadasu¹,

None Bharani²

Abstract: A fast, sensitive, and reliable RP-HPLC method involving cyberlab HPLC System with PDA detection was developed and validated for the quantification of Aclidinium bromide and Formoterol fumarate in inhalation preparations. Chromatography was performed on the Inertsil -ODS C18 (250 x 4.6mm, 5μ) column using filtered and mixed degassed methanol: buffer (75:25 v/v) as a mobile phase with a flow rate of 1.0mL/min and the column effluent was monitored at 240nm. Retention times for Aclidinium bromide 4.713min and For… Show more

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Simultaneous Quantification of Mometasone Furoate and Formoterol Fumarate in Bulk and Formulations by RP-HPLC Method

Kumar V

et al. 2023

AJPA

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A simple and robust reversed-phase high pressure liquid chromatographic method was developed and validated for the quantification of Mometasone and Formoterol in bulk and fixed dosage forms. The column utilized for study was Inertsil C18, ODS was chosen for good peak shape. Ambient temperature was found to be suitable for the nature of drug solution. The mobile phase was streamlined with a ratio of 35:65 Methanol: Water was optimized for symmetrical peaks and good resolution. The flow rate was streamlined at 1.0 ml/min because of good peak area, satisfactory retention time and good resolution. Common λ-max was found to be at 278 nm and Injection volume was 20 µl which gave a good peak area. The percentage recovery was found to be 98.0-101.50 was linear and precise over the same range. Both system and method precision was found to be accurate and well within the acceptable limits. Detection limit was found to be 0.25 Mometasone and 0.34 for Formoterol. The analytical method was found linearity over the range of 20-80 ppm of the target concentration for both the drugs. The LOD and LOQ values for Mometasone, was observed to be 0.25 and 0.77 and for Formoterol was in the range of 0.34 and 1.05 consecutively. The analytical method passed both intermediate precision and robustness tests. On both cases, relative standard deviation was well satisfactory. The validation experiments met ICH standards. It inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.

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Simultaneous Quantification of Mometasone Furoate and Formoterol Fumarate in Bulk and Formulations by RP-HPLC Method

Kumar V

et al. 2023

AJPA

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show abstract

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Development and Validation of RP-HPLC Method for Analysis of Aclidinium Bromide and Formoterol Fumarate in Pharmaceuticals

Cited by 1 publication

References 10 publications

Simultaneous Quantification of Mometasone Furoate and Formoterol Fumarate in Bulk and Formulations by RP-HPLC Method

Simultaneous Quantification of Mometasone Furoate and Formoterol Fumarate in Bulk and Formulations by RP-HPLC Method

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