New Validated Stablity Indicating RP-HPLC Bioanalytical Method Development and Validation for Simultaneous Estimation of Hydrochlorothiazide, Ramipril and Losartan in Human Plasma by Using PDA Detector

23 Pages Posted: 12 Jul 2017

See all articles by S Ashutosh Kumar

S Ashutosh Kumar

Godavari Institute of Engineering and Technology

Manidipa Debnath

A.K.R.G. College of Pharmacy - Department of Pharmaceutics

J. V. L. N. Seshagiri Rao

Srinivasa Rao College Of Pharmacy - Department of Pharmaceutical Analysis and Quality Assurance

D. Gowri Sankar

Andhra University - Department of Pharmaceutical Analysis and Quality Assurance

Date Written: June 6, 2016

Abstract

A precised and reproducible stability indicating RP-HPLC method was developed for the simultaneous estimation of hydrochlorothiazide, ramipril and losartan potassium in plasma by using Symmetry C18 column (4.6 x 150mm, 5Pm, Make: Hypersil) in an isocratic mode. The drug was spiked in the plasma and extracted with mobile phase by precipitation method. The mobile phase was consisted of potassium dihydrogen phosphate (KH2PO4) and acetonitrile [HPLC Grade] in the ratio of 68:32 (% v/v). The detection was carried out at 210 nm. The percentage mean recoveries of hydrochlorothiazide, ramipril and losartan potassium were found to be 98.21-101.13, 98.82-100.93 and 99.69-100.98 percentage respectively. This reveals that the method is quite accurate. The method was linear over the concentration range for hydrochlorothiazide 12.5-32.5, ramipril 1.25-3.25 and losartan 50.0 -130.0 Pg/mL. The percentage relative standard deviation for inter-day and intra-day precision was found to be within limits. The lower limit of quantification was found to be 0.647, 1.283 and 2.647 µg/mL for hydrochlorothiazide, ramipril and losartan respectively. The percentage relative standard deviation obtained for the drugs spiked in plasma for stability studies were less than 2 %. The validation of method was carried out utilizing ICH-guidelines.

Keywords: Losartan potassium, Ramipril, Hydrochlorothiazide, Validation, RP-HPLC, Bioanalytical method

Suggested Citation

Ashutosh Kumar, S and Debnath, Manidipa and Seshagiri Rao, J. V. L. N. and Sankar, D. Gowri, New Validated Stablity Indicating RP-HPLC Bioanalytical Method Development and Validation for Simultaneous Estimation of Hydrochlorothiazide, Ramipril and Losartan in Human Plasma by Using PDA Detector (June 6, 2016). Available at SSRN: https://ssrn.com/abstract=2791168 or http://dx.doi.org/10.2139/ssrn.2791168

S Ashutosh Kumar (Contact Author)

Godavari Institute of Engineering and Technology ( email )

Rajahmundry, Andhra Pradesh
India

Manidipa Debnath

A.K.R.G. College of Pharmacy - Department of Pharmaceutics

Nallajerla
West Godavri, Andhra Pradesh 534112
India

J. V. L. N. Seshagiri Rao

Srinivasa Rao College Of Pharmacy - Department of Pharmaceutical Analysis and Quality Assurance

Pothina Mallayya Palem
Madhurawada
Visakhapatnam, Andhra Pradesh 530041
India

D. Gowri Sankar

Andhra University - Department of Pharmaceutical Analysis and Quality Assurance

Visakhapatnam, Andhra Pradesh
India

Here is the Coronavirus
related research on SSRN

Paper statistics

Downloads
25
Abstract Views
398
PlumX Metrics