Separation and identification of a complex flurbiprofen-polyethylene glycol mono- and diester mixture via a hyphenated HPLC-DAD-HRMS/SPE NMR system

Schmidt, Philipp; Kolb, Christine; Godejohann, Markus; Reiser, Andreas; Philipp, Markus; Müller, Hans-Christian; Karaghiosoff, Konstantin

doi:10.1016/j.jpba.2022.115068

Journal of Pharmaceutical and Biomedical Analysis

2023

DOI: 10.1016/j.jpba.2022.115068

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Separation and identification of a complex flurbiprofen-polyethylene glycol mono- and diester mixture via a hyphenated HPLC-DAD-HRMS/SPE NMR system

Philipp Schmidt

Christine Kolb

Markus Godejohann

et al.

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“…Ultraviolet (UV) spectrophotometry can be used to study of flurbiprofen and its degraded components under stress conditions. According to ICH recommendations [23][24][25][26] , determination of flurbiprofen in various synthetic and di ester mixture analysis including characterization [27,28] . The active pharmaceutical ingredient is compelled to degrade in a number of conditions, including acidic, basic and oxidative degradation.…”

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Quantification of Flurbiprofen in Eye Drops by Stability Indicating Ultraviolet Spectrophotometric Method

Ponnam¹,

Naidu²,

Yarraguntla³

2023

IJPS

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An efficient, rapid, sensitive, validated stability-indicating ultraviolet spectrophotometric method was developed for flurbiprofen in eye drops. Methanol was employed as the solvent in this proposed process, and detection was carried out at a wavelength of 248 nm. The validation parameters linearity, limit of detection and limit of quantitation, accuracy, precision and specificity were all the subject of experiments according to International Council on Harmonisation guidelines. The stability of flurbiprofen was examined under acidic, alkaline, thermal, and photolytic conditions. The kinetics in the concentration range of 2-10 ug/ml were defined as linear with a correlation value of 0.992. The percentage of relative standard deviation for both intra-day and inter-day accuracy was under less than 2 % and 99.6 %-100.4 % of the drug was retrieved from the study. The system was able to identify variations related to stress conditions although the stress condition of degradation products hadn't been determined. The proposed approach can be employed as a stability indicating method for flurbiprofen screening in conventional pharmaceutical analysis of eye drops with a significant level of linearity, accuracy and precision. The method was found to be both affordable and convenient. This method can therefore be used to study flurbiprofen stress degradation behaviour in small industries without access to sophisticated equipment.

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mentioning

confidence: 99%

Quantification of Flurbiprofen in Eye Drops by Stability Indicating Ultraviolet Spectrophotometric Method

Ponnam¹,

Naidu²,

Yarraguntla³

2023

IJPS

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Separation and identification of a complex flurbiprofen-polyethylene glycol mono- and diester mixture via a hyphenated HPLC-DAD-HRMS/SPE NMR system

Cited by 1 publication

References 26 publications

Quantification of Flurbiprofen in Eye Drops by Stability Indicating Ultraviolet Spectrophotometric Method

Quantification of Flurbiprofen in Eye Drops by Stability Indicating Ultraviolet Spectrophotometric Method

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