http://dx.doi.org/10.4314/tjpr.v12i2.15
Abstract
Purpose: To develop and validate a dissolution test method
for tablets containing 80 mg of drotaverine
hydrochloride (DRT) and 250 mg of mefenamic acid (MEF).
Methods: Sink conditions, drug stability and
specificity in different dissolution media were tested
to optimize a dissolution test method using a USP paddle
type dissolution test apparatus set at a speed of 50
rpm. The dissolution medium consisted of 900 ml of
phosphate buffer (pH 6.8) containing 0.25% w/v cetrimide
at 37 ± 0.5 oC and 45 min time-point. To
determine both drugs simultaneously, a first derivative
UV spectrophotometric method was developed and
validated. Drug release was analyzed by first derivative
UV method at 253.8 nm and 304 nm for DRT and MEF
respectively. The dissolution method was validated as
per ICH guidelines.
Results: The two brands each showed 98 % of
drug release for both drugs when the developed
dissolution method was used. The regression plot was
linear in the concentration range 4 - 24 µg/mL for each
of the drugs and regression coefficient (r2)
was greater than 0.999 for each drug. Relative standard
deviation (% RSD) for precision and accuracy of proposed
method was < 2.
Conclusion: The proposed dissolution method is
simple, cost-effective, precise, accurate and specific.
It can be successfully employed in routine quality
control of DRT and MEF combination tablets.
Keywords:
Drotaverine hydrochloride, Mefenamic acid, First
derivative spectrophotometry, Dissolution, Validation
