Application of Multivariate Calibration Methods for Simultaneous Determination of Drugs in Fixed Dose Combination. Gandhi Santosh V.1,*, Khairnar Parag L.1, Chaudhari Atul P.2 1AISSMS College of Pharmacy, Kennedy Road, Near R. T. O., Pune-411001, Maharashtra, India 2Smt. S. S. Patil Institute of Technology (Pharmacy), Chopda-425107, Dist. Jalgaon, Maharashtra, India *Corresponding Author E-mail: santoshvgandhi@rediffmail.com
Online published on 2 June, 2018. Abstract This presented work is based on application of two multivariate calibration methods for simultaneous UV-Vis spectrophotometric determination of active substances in combined pharmaceutical formulation composed of Nitazoxanide and Ofloxacin. Chemometrics is statistically improved and verified multicomponent method for analysis. The methods used were Principal Component Regression (PCR) and Partial Least Square (PLS). The Spectra of drugs were recorded at concentrations in the linear range 5.0–30.0 μg/ml and 2.0–12.0 μg/ml of Nitazoxanide and Ofloxacin, respectively. 32 set of mixtures were used for calibration and 11 set of mixtures were used for validation in the wavelength range of 280 to 360 nm with the wavelength interval λ= 0.5 nm in methanol. The methods were validated as per International Conference on Harmonization Q2 (R1) (ICH) guidelines. These methods were successfully applied for determination of drugs in pharmaceutical formulation (tablet) with no interference of the excipients as indicated by the recovery study results. The proposed methods are simple, rapid and can be easily used as an alternative analysis tool in the quality control as well as in process control of drugs and formulation. Top Keywords Nitazoxanide, Ofloxacin, PLS, PCR, Validation. Top |