Development and
Validation of a Stability-Indicating RP-HPLC Method for
Simultaneous Determination of Paracetamol, Tramadol HCl
and Domperidone in a Combined Dosage Form
K Karunakaran1*, G
Navaneethan1 and KP Elango2
1Department
of Sciences, Sona College of Technology (Anna
University), Salem 636 005, 2Department of
Chemistry, Gandhigram Rural Institute (Deemed
University), Gandhigram 624 302, India
*For correspondence:
Email:
drkk@sonatech.ac.in
Tel:
+91 427 4099998; Fax: +91 427 4099989
Received: 4 March
2011 Revised
accepted: 7 December 2011
Tropical Journal of
Pharmaceutical Research, February 2012; 11(1):
99-106
http://dx.doi.org/10.4314/tjpr.v11i1.13
Abstract
Purpose:
To develop a stability indicating RP-HPLC method for a
combination drug product containing a high dose of
paracetamol (PR) and low doses of domperidone (DM) and
tramadol HCL (TR).
Methods:
The analytes are well separated by a
reverse phase column and an isocratic mobile phase
consisting of 0.1 %v/v trifluoroacetic acid:
acetonitrile: methanol in the ratio 70:25:5 (v/v) with a
flow rate of 1.0 mL/min. The effluent was monitored at
272 nm. The drug products were subjected to stress
conditions of acid, base, peroxide, thermal and
photolytic degradation and peak homogeneity of PR, TR
and DM were obtained using photo diode array detector.
Results:
The degradation products were well
resolved from PR, TR and DM peaks, thus indicating the
stability-indicating nature of the method. The assay was
linear from 165 – 495 µg/mL
for PR, 18.75 – 56.25 µg/mL
for TR, and 5 – 15 µg/mL for
DM. Although the tablet contained high and low doses of
the drugs, the intra- and inter-day variations were <
2.0 %.
Conclusion:
The proposed method was validated according to the ICH
guidelines and proved suitable for stability and
homogeneity testing, as well as for quality control of
the combined drugs in pharmaceutical preparations.
Keywords: HPLC, Isocratic, Peak purity,
Simultaneous determination, Paracetamol, Tramadol,
Domperidone.
