Analytical method for simultaneous estimation of efonidipine hydrochloride ethanolate and telmisartan by validated RP-HPLC method

Koli Priyal, Dudhrejiya Ashvin, Patel Ashok, Chavda Jayant

B. K. Mody Government Pharmacy College, polytechnic campus, Rajkot, Gujarat, India

ABSTRACT

This research aimed to develop and validate a specific, precise, accurate, robust and cost-effective reversed phase high performance liquid chromatoghraphic method for simultaneous quantification of Efonidipine Hydrochloride Ethanolate and Telmisartan in synthetic mixture. Efonidipine Hydrochloride Ethanolate is a L- and T- type dual calcium channel blocker and Telmisartan is angiotensin receptor blocker given in patient having essential hypertension associated with diabetes and no produced reflex tachycardia. The literature survey disclosed no reported method available for simultaneous eatimation method for this combination. Hence, an attempt was made to develop and validate the reversed phase high performance liquid chromatoghraphic method. In developed RP-HPLC method, analytes sepration were employing Waters C18 Column (150 mm × 4.6 mm, 5 μm). The quantification is carried out using mobile phase Potassium Dihydrogen Orthophosphate: Acetonitrile (30:70 v/v %) containing 1 % orthophosphoric acid were mixed to adjust pH 3. Area were recorded at 254 nm for both analytes and retention time was found to be 7.933 min and 3.187 min for Efonidipine Hydrochloride Ethanolate and Telmisartan at 0.8 ml/min flow rate. The estimation method validated according to the ICH Q2 (R1) guideline. The validated data represent that the develop method was linear over a concentration range of 5-30 μg/ml for Efonidipine Hydrochloride Ethanolate and 10-60 μg/ml Telmisartan.The Accuracy in terms of mean percent recovery for the analytes was found in the range of 98-100.10 % and 98.31-100.10 % both drugs respectively. The method was precise and reliable with relative standard deviation of lower than 2 %. The detection limit found for Efonidipine Hydrochloride Ethanolate 0.028 μg/ml and 0.032 μg/ml of Telmisartan. This simple, reliable and precise method can be used for estimation of both drug in quality control laboratories.

Keywords:

Efonidipine Hydrochloride Ethanolate, ICHQ2 (R1), RP-HPLC, Synthetic Mixture, Telmisartan