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HPLC Determination of N-Methylethanolamine in Diphenhydramine Hydrochloride Drug Substance by Pre-column Derivatization

Anerao A.a*, Dighe V.a, Gupta A.a, Patil C.a and Pradhan N. a

a R&D centre (API), Wanbury Ltd., EL-16, TTC Industrial Estate, Mahape, Navi Mumbai - 400 710, Maharashtra, India
* For correspondence: E-mail:


N-Methylethanolamine is the side chain of the drug diphenhydramine hydrochloride. A sensitive high performance liquid chromatography method with pre-column derivatization was developed and validated for the determination of N-methylethanolamine impurity in diphenhydramine hydrochloride active pharmaceutical ingredient. HPLC method on column Cosmosil MS-II, C-18, 250 mm X 4.6 mm, particle size 5 μm with UV detector was used. The proposed method is specific, linear, accurate, rugged and precise. The calibration curves showed good linearity over the concentration range of 0.03 mg/g to 1.5 mg/g and the correlation coefficient was 0.999. Method had very low limit of detection (LOD) and limit of quantification (LOQ) as 0.01 mg/g and 0.03 mg/g, respectively, of the analyte. Accuracy was observed within 94.4% to 96.2%.

Year 2018 | Volume No. 55 | Issue No.10 | Page No. 56-62
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