Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
47, Number 7, August 2009, pp. 589-593
Stress Degradation Studies on Duloxetine Hydrochloride
and Development of an RP-HPLC Method for its Determination in
Capsule Formulation
V.R. Sinha1, Anamika1, R. Kumria3,
and J.R. Bhinge1,2
1University Institute of Pharmaceutical Sciences, Panjab University,
Chandigarh-160014, India;
2Center with Potential for Excellence in Biomedical
Sciences, Panjab University, Chandigarh-160014, India; and
3Ind-Swift
Laboratories Limited, Parwanoo, India
Duloxetine hydrochloride (HCl) is an antidepressant
drug prescribed for major depressive disorders, pain related
to diabetic peripheral neuropathy, and stress urinary incontinence.
In the present study, degradation behavior of duloxetine HCl
was studied by subjecting the drug to various International Conference
on Harmonization-recommended stress conditions. Also, a stability-indicating
high-performance liquid chromatography method was established
for analysis of the drug in the presence of various degradation
products. An acceptable separation of the drug and its degradation
products was achieved on a C-8 column at 40°C using a mobile
phase comprised of phosphate buffer (pH 2.5)–methanol–tetrahydrofuran
in the ratio of 50:40:10 at a flow rate of 1 mL/min. The detection
wavelength was 232 nm. The method was validated for linearity,
precision, accuracy, selectivity, specificity, and robustness.
The method was found to be linear over a concentration range
of 1–100 µg/mL (n = 6). The value of slope
was found to be 85.735 mV/s ppm with correlation coefficient
of 0.9994 and relative standard deviation (RSD) of 0.87%. RSD
values ranged from 0.20% to 0.82% in the case of intra-day precision
studies, whereas the values ranged from 0.63% to 1.57% in the
case of inter-day precision. The drug was found to be stable
on exposure of 30% H2O2 for 48 h. It was
found to be highly unstable in acidic conditions, as 41.35% degradation
was observed in 0.01N HCl at 40°C after 8 h. Degradation
was also observed in alkaline and neutral conditions (2.83% and
42.75%, respectively) on refluxing the drug for 1 h. The drug
was stable under photolytic and thermal stress on exposure in
solid form but showed considerable degradation in solution form.
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