Stability Indicating RP-HPLC Method Development and Validation of Anti-Diuretic Drugs in a Combined Dosage Forms

Dr. CH K V L S N Anjana Male | K. Lurdy Mary | Boddu Aruna

Abstract: Eprosartan is as Angiotensin Conversion enzyme inhibitor, Hydrochlorothiazide is a benzo-thiadiazine acts as diuretic. Very less amount of research was carried out in the combined dosage of these drugs an attempt has been developed using RP-HPLC for combined dosage form and the method is validated as per ICH guidelines. Chromatographic separation of Eprosartan and Hydrochlorothiazide was achieved on Shimadzu HPLC with Phenomenex C18 column of having 5 � particle size, 50% methanol and 50% of O-phosphoric acid was used as mobile with 0.8ml/min flow rate constats were detected by using UV-visible detector at a 232 nm Hydrochlorothiazide and Eprosartan are 2.5 and 4.3 minutes respectively were detected from the retention time. Further stress conditions like Photostability, acid stability, alkaline and oxidation conditions were detected for identification of degradation. Optimized method was a good approach for obtaining reliable results and found to be suitable for the routine analysis of Hydrochlorothiazide and Eprosartan in combined dosage form.

Keywords: Eprosartan, Hydrochlorothiazide, degradation studies, RPHPLC

Edition: Volume 11 Issue 11, November 2022,

Pages: 765 - 769