Multivariate UV-Chemometric and HPLC-QbD Method for Simultaneous Estimation of Vardenafil and Dapoxetine in Active Pharmaceutical Ingredients and its Marketed Formulation

M. Patel, C. Kothari

2020

10 citations

Abstract

This manuscript focuses on Novel multivariate UV-chemometric method and

HPLC-QbD method for simultaneous determination of Vardenafil (VR) and Dapoxetine (DP) in active

pharmaceutical ingredient and their marketed formulation. To the best of our knowledge, there is no

literature data on multivariate methods for the same.

The spectrophotometric data were processed by CLS, PCR, PLS and MLR methods in order

to determine the active substances, without prior separation from tablet marketed formulation. Analytical

figures of merit, such as sensitivity, selectivity, analytical sensitivity, LOD, and LOQ were determined.

In HPLC-QbD, four critical factors were selected after screening and boxbehnken design was

applied for optimization. Twenty-five experiments were done, and a quadratic model was used for all

response variables. Desirability plot, surface plot, design space, and three-dimensional plots were calculated.

For Chemometrics, wavelength range selected was 202 nm - 326 nm at 2 nm intervals, hence

59 wavelength points were selected in such a way that minimum RMSEC and RMSECV values were

obtained at multiple wavelengths. HPLC-QbD optimized conditions were; Phenomenex C8 column

(250 × 4.6 mm, 5 μm), acetonitrile: buffer (ammonium acetate buffer at pH 2.7 with acetic acid) (40:60,

v/v) as a mobile phase at flow rate of 0.9 mL/min, 239 nm wavelength and 20°C temperature.

The developed methods were validated and successfully applied for simultaneous determination

of VR and DP in…

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