RP-HPLC and UV Methods for Simultaneous Estimation of Fixed Dose Combinations of Cinnarizine and Piracetam: Simultaneous Equation, Experimental Design and Statistical Correlation

The current study represents the development and validation of UV spectroscopic
and HPLC methods for simultaneous estimation of Cinnarizine and Piracetam in their combined
formulation by using design of experiments (DoE). In UV spectroscopy method, Cinnarizine
and Piracetam were determined by using simultaneous equation method. Methanol was used
as solvent. 250 nm and 229 nm wavelengths were selected for the estimation of Cinnarizine and
Piracetam. In RP-HPLC method, three independent factors like; Organic solvent composition,
Buffer pH and flow rate was employed. Central composite design (CCD) was applied and also
to study the response surface methodology. Capacity factor, Retention time and Resolution
were simultaneously optimized by using Desirability function for HPLC method. The proposed
RP-HPLC method, the optimized and predicted data consisted of mobile phase Acetonitrile:
Orthophosphoric acid (pH 2.8 with Orthophosphoric acid) in the ratio of 40:60% v/v
respectively, at a flow rate of 0.7 ml/min and wavelength of 229nm.For UV, the linearity ranges
from 4-24 µg/ml for cinnarizine and 80-480 µg/ml for Piracetam. For HPLC, the linearity ranges
from 2-12 µg/ml for cinnarizine and 40-240 µg/ml for Piracetam .The optimized both method
conditions were validated according to International Council for Harmonisation (ICH)
guidelines. The Student’s t-test and Two way analysis of variance (ANOVA) were used to
correlate the results of Cinnarizine and Piracetam determination in dosage form by means of
UV and HPLC method. The proposed methods can be routinely employed in quality control for
the analysis of Cinnarizine and Piracetam in the pharmaceutical dosage forms.