Abstract

DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE METHOD FOR THE SIMULTANEOUS ESTIMATION OF TELMISARTAN AND NIFEDIPINE IN SYNTHETIC MIXTURE

*Modi Dixita V. and Patel Paresh U.

Abstract

A first order derivative spectrophotometry method is developed for the simultaneous determination of Telmisartan (TEL) and Nifedipine (NIF) in synthetic mixture. This method is simple, precise, accurate and economical. The work was carried out on Shimadzu model 1800 (Japan) double beam UV visible spectrophotometer with spectral width of 2 nm, wavelength accuracy of 0.5 nm and a pair of 10 mm matched quartz cell was used to measure absorbance of all the solutions. Distilled methanol was used as a solvent. The linearity range for both the drugs TEL and NIF were 1-18μg/ml and 2-20μg/ml. The spectra of the drug were converted to the first derivative forms and the ZCP’s (Zero Crossing Points) were obtained. The absorbance of the TEL was measured at 235.7nm (ZCP of NIF) and for the NIF was measured at 252.1 nm (ZCP of TEL). The results of the analysis of synthetic mixture by the proposed method is highly reproducible and reliable and it is in good agreement with the label claim of the drug. This method can be used for the routine analysis of the TEL and NIF in synthetic mixture without any interference of excipients.

Keywords: Telmisartan (TEL), Nifedipine (NIF), First order derivative spectrophotometry, Synthetic mixture, Validation, ICH Guidelines, Recovery.