Implementation of QBD Approach to the Analytical Method Development and Validation for The Estimation Of Cilnidipine and Nebivolol in Tablet Dosage Form

Prasanna Ku. Pradhan¹*, T. Y. Pasha², N. M. Mehta ¹, Anil Bhandari¹

Jodhpur National University, Jodhpur¹

Baroda College of Pharmacy, Vadodara²

Correspondence :prasanna.k.pradhan@gmail.com

ABSTRACT

A Second Derivative UV Spectroscopic method was developed for the analysis of Cilnidipine (CIL) and Nebivolol HCl (NEB) in its combined dosage according to Quality by design (QbD) to ensure predictable quality with desired and predetermined specifications. As per QbD approach variable parameters were identified designed into Ishikawa diagram. Screenings of critical parameters were done by observation as well as Principal Component Analysis. Screened critical parameters for the method were solvent methanol, sample preparation tablet and matrix, wavelength: 232.6 nm for NEB and 263.8 nm for CIL, slit width: 1.0, scan speed medium, sampling interval: 0.2 and amplification factor 500. With the above set of critical parameters validation was performed as per ICH Q2 (R1) guidelines. Method was found to be accurate, precise and hence can be useful for routine analysis of CIL and NEB in tablet dosage form simultaneously.

Keywords : Quality by design, Second Derivative UV Spectroscopic method, Cilnidipine, Nebivolol HCl, Validation.