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ZENODO
Article . 2025
License: CC BY
Data sources: ZENODO
ZENODO
Article . 2025
License: CC BY
Data sources: Datacite
ZENODO
Article . 2025
License: CC BY
Data sources: Datacite
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Novel Stability Indicating RP-UPLC Method Development and Validation for The Quantification of Nefopam Hydrochloride in Tablet Dosage Form and Characterization of Its Degradation Products

Authors: Hariharan T.1*, P. G. Sunitha2, N. Deattu3, Silambarasan D.4, Mageshwari A.5, Hemanath R.6, Jawaharsamuvel R.7;

Novel Stability Indicating RP-UPLC Method Development and Validation for The Quantification of Nefopam Hydrochloride in Tablet Dosage Form and Characterization of Its Degradation Products

Abstract

A novel stability indicating RP-UPLC method has been developed for the estimation of Nefopam hydrochloride in bulk and pharmaceutical dosage form. The Chromatographic separation was achieved on C18 (4.6 mm * 100 mm; 3 microns) column using the mobile phase buffer: acetonitrile: methanol in the ratio of 50:41:9 at a flow rate of 0.6 ml/min. The detection wavelength was 225 nm. Linearity was obeyed in the concentration of 22.63 µg/ml to 67.90 µg/ml. The recovery of Nefopam was found to be 99.72 %. In precision study % RSD was found to be 0.47 for repeatability and 0.60 % for intermediate precision. By using the developed method, percentage label claim of marketed formulation was found to be 100.39%. Forced degradation studies showed significant degradation under Acid hydrolysis. This UPLC method is suitable for routine quality control of Nefopam hydrochloride in pharmaceutical formulation, effectively distinguishing degradation products and ensuring regulatory compliance.

Keywords

Nefopam hydrochloride, NSAID, Validation, ICH guidelines, Forced degradation, stability indicating method.

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
Green