Analytical Method Development and Validation ...

Analytical Method Development and Validation for Telmisartan, Chlorthalidone and Amlodipine by RP-HPLC Method

Author Name : R. M. Sanap, S. R. Wavhale, V.V. Kunjir, Dr. R. V. Shete

ABSTRACT

 A simple, sensitive and accurate RP-HPLC method has been developed for simultaneous determination of Telmisartan, Amlodipine and Chlorthalidone in combined tablet dosage form.Literature survey reviews that there are various methods are reported for Telmisartan in single or in with combination with other drugs. But, no any RP-HPLC method is available for Telmisartan, Amlodipine and Chlorthalidone. A HPLC– Shiseido Model LC-2030 PLUS(IND) System Consisting of Kromasil, C8 4.6 mm x 250 cm, 5µcolumn with Mobile phase Potassium dihydrogen Orthophosphate, Acetonitrile was used. The flow rate was 1.0mL/minute and effluent monitored at 228nm.The Linearity range was found to be 80 to 280ppm of Telmisartan, 25 to 87.5ppm of Chlorthalidone and 10 to 35ppm of Amlodipine. In Precision studies the System Precision and Method Precision study was found to be less than 2%. The accuracy studies shown % recovery for Telmisartan, Chlorthalidone and Amlodipine in the range 100.1-100.5%, 99.6-100% and 100-101%. The proposed method was validated statistically. Thus, the method was simple, precise, economic, rapid, accurate and can be successfully applied for simultaneous determination of Telmisartan, Amlodipine and Chlorthalidone in combined tablet dosage form.

Key Words: Amlodipine, Chlorthalidone, RP-HPLC, Telmisartan, Validation.