Abstract

A RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF SAMLODIPINE AND LOSARTAN POTASSIUM IN COMBINED DOSAGE FORMS

Dr. Praveen Kumar Ashok, Ms. Anisha Arya, Moinuddin Mikrani*

Abstract

A simple, accurate, precise and sensitive analytical RP-HPLC method was developed for the determination of S-amlodipine and Losartan Potassium in tablet form. The mobile phase used was a mixture of 55 volumes of phosphate buffer ph 5.0 prepared by dissolving 0.68 g of potassium Di-hydrogen orthophosphate and 4.0 ml tri-ethylamine in 1000 ml of water, adjust to pH 5.0 with dilute Ortho phosphoric acid, 22 volumes of acetonitrile and 18 volumes of methanol. A stainless steel column of 250mm x 4.6 mm, packed with octylsilane bonded to porous silica (5μm) was used, with flow rate 1.5 ml/min, wavelength 237 nm and injection volume 20 μl. The optimized method was then validated as per ICH guidelines Q2 [R1]. The method was linear over the concentration range 80% -120%. The percentage recoveries of Samlodipine and Losartan Potassium were 101.13% and 100.88 % respectively. The assay results obtained by two analysts using two instruments on different days had a statistical RSD less than 2%.The method was also found to be robust and rugged. All of the validation parameters were within the acceptance criteria as per the ICH guidelines. Hence the proposed method can be used for the routine control analysis of S-amlodipine and Losartan Potassium in combined dosage form.

Keywords: S-amlodipine, Losartan Potassium, Analytical method validation, HPLC.