APPLICATION OF MULTIVARIATE CALIBRATION METHODS FOR SIMULTANEOUS DETERMINATION OF ANTIRETROVIRAL DRUGS IN FIXED DOSE COMBINATION
Santosh V. Gandhi* and Amit S. Mutha
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 Lamivudine (LAM) and Tenofovir Disoproxil Fumarate (TDF). The methods used were Principal Component Regression (PCR) and Partial Least Square (PLS). The Spectra of LAM and TDF were recorded at concentrations within their linear range 5.0-30.0 μg/ml for both drugs. 28 set of mixtures were used for calibration and 12 set of mixtures were used for validation in the wavelength range of 240 to 280 nm with the wavelength intervals λ= 0.5 nm in methanol. The methods were validated as per International Conference on HarmonizationQ2 (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.
Keywords: Lamivudine, Tenofovir Disoproxil Fumarate, PLS, PCR, Validation.
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