Spectrophotometric simultaneous determination of efonidipine hydrochloride ethanolate and telmisartan in synthetic mixture by first order derivative method

Ashvin Dudhrejiya, Ashok Patel, Jayant Chavda, Dhruvanshi Gol, Priyal Koli

Department of Pharmaceutical Quality Assurance, B. K. Mody Government Pharmacy College, polytechnic campus, Rajkot, India

ABSTRACT

The established method represents the development and validation of a straight forward, precise, accurate, specific and reproducible method for the simultaneous estimation of Efonidipine Hydrochloride Ethanolate and Telmisartan in synthetic mixture. First order derivative of the overlay spectra was used for quantification of both drugs. This method involving the determination of both drugs at their respective zero crossing point working wavelength was observed 231.00 nm (Zero crossing point of Telmisartan) for Efonidipine hydrochloride ethanolate and 238.60 nm (Zero crossing point of Efonidipine Hydrochloride Ethanolate) for Telmisartan using methanol as diluent. International conference on harmonization (ICH) (Q2R1) guideline was used for method validation. The Beer-Lambert’s law obeyed in the concentration range of 2-18 μg/ml and 4-36 μg/ml for Efonidipine Hydrochloride Ethanolate and Telmisartan, respectively. The percentage recovery was found in the range of 98-101 % of Efonidipine Hydrochloride Ethanolate and 98.46-99.77% of Telmisartan. The % relative standard deviation of precision and repeatability study was found beneath 1%. This simple and precise method can be used of both drugs in quality control laboratories.

Keywords:

Efonidipine Hydrochloride Ethanolate, First order derivative, ICH Q2 (R1), Telmisartan, UV spectroscopy