Green Analytical Method Development and Validation of Irbesartan and Hydrochlorothiazide

Abstract

The Green chemistry and Quality by Design (QbD) concepts were combined to achieve the dual goals of environmental friendliness and robustness in a single process. IRB and HCT are the potent antihypertensive drugs and as per the literature review different HPLC, HPTLC methods have been already published for the validation of IRB & HCT but no green method was reported with the application of both concepts like GAC and QbD. Green-NP-HPTLC & Green-RP-HPTLC method have been developed & validated for the estimation of IRB and HCT drug substance & drug products. The G-NP-HPTLC study was performed by utilizing Silica Gel 60 F254 and for G-RP-HPTLC method TLC Silica gel 60 RP-18 F254s is used. The QbD technique was used to optimize the technique using the Central composite design. The procedure was validated successfully for the estimation of IRB & HCT drug and formulation. The mobile phase composition, chamber saturation time and band width were selected as critical variables and area and retention factor were selected as response variables for the designing and optimization of method. The green solvents like Ethanol: Ethyl acetate (50:50 v/v) and Propanol: water in (60:40 v/v) ratio was utilized as the M.P & the Rf = 0.52±0.02 , Rf = 0.60±0.01 for G-NP-HPTLC-IRB and G-RP-HPTLC-IRB respectively, The quantitation was carried out at λmax=220nm for both the techniques .The proposed G-NP-HPTLC-IRB & G-RP-HPTLC-IRB methods were determined to be linear between the range of 200-1000 ng/band with R2 = 0.9994 & 200 - 600ng/band with R2 = 0.999. The green solvents like Butyl acetate: methanol (90:10v/v) and Ethanol: Water (80:20v/v) was used as mobile phase & the Rf = 0.53±0.02, Rf = 0.75±0.02 for Green-NP-HPTLC-HCT & Green-RP-HPTLC-HCT respectively and their quantification was done at λmax=270nm for both techniques. The proposed Green-NP- HPTLC-HCT & Green-RP-HPTLC-HCT methods were linear in the range of 200- 800ng/band having R2 = 0.9991 & 200-600ng/band, R2 = 0.9998 respectively. The proposed Green HPTLC techniques were validated for linearity, precision, accuracy, robustness, LOD and LOQ. ICH guidelines were followed for the validation, and the results shows that they can be applied for regular analysis in QC labs with compatible results. The Green-RP-HPTLC techniques were found more precise, rapid, accurate & robust for the