Abstract
Duloxetine hydrochloride is a potent dual reuptake inhibitor of serotonin and norepinephrine used to treat major depressive disorders. The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. The chromatographic separation was carried out on precoated silica gel 60 F254 aluminium plates using mixture of chloroform:methanol (8:1 v/v) as mobile phase and densitometric evaluation of spots was carried out at 235 nm using Camag TLC Scanner-3 with win CAT 1.3.4 version software. The experimental parameters like band size of the spot applied, chamber saturation time, solvent front migration, slit width etc. were critically studied and optimum conditions were evolved. The drug was satisfactorily resolved with Rf value 0.11±0.01. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (40-200 ng/spot), precision (intra-day RSD 0.46-0.75%, inter-day RSD 0.46-1.59%), accuracy (98.72±0.20) and specificity according to ICH guidelines. The proposed method can analyse ten or more formulation units simultaneously on a single plate and provides a faster and cost-effective quality control tool for routine analysis of duloxetine hydrochloride as bulk drug and in tablet formulation.
Highlights
Duloxetine hydrochloride is a potent dual reuptake inhibitor of serotonin and norepinephrine used to treat major depressive disorders
Duloxetine hydrochloride (DH), chemically (+)-(S)-Nmethyl-3-(1-naphthyloxy)-3-(thiophen-2-yl)-propan-1amine is a drug that primarily targets major depressive disorders and pain related to diabetic neuropathy[1,2,3]
Literature review reveals that several HPLC 4-6 and LC-MS 7 methods have been reported for estimation of duloxetine hydrochloride in single and combined form with other drugs, but no HPTLC method is reported so far
Summary
Duloxetine hydrochloride is a potent dual reuptake inhibitor of serotonin and norepinephrine used to treat major depressive disorders. 0.1 milliliter of the above solution was further diluted with methanol to obtain the concentration 0.02 μg/μl of duloxetine hydrochloride. The tablets were Þnely powdered and powder equivalent to 20 mg of duloxetine hydrochloride was accurately weighed and dissolved in 10 ml of methanol to obtain the concentration of 2 μg/μl.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
