analysis method of Losartan Potassium and Hydrochlorothiazide
To lay down a procedure for analysis of Losartan Potassium and Hydrochlorothiazide Tablets
This STP is applicable to Quality Control in formulation plant
QC. Officer /Head-quality Control
05 ASSAY: Each film coated tablet contains :
Losartan Potassium IP 50 mg.
Hydrochlorothiazide IP 12.5 mg
Instrumental Conditions :
Column : C18 Column (250×4.6mm, 5ųm)
Flow Rate : 1.2 ml/min
Wave Length : 272nm
Injection Volume : 20ųl
Column temperature : Ambient
Run time : 10min
BUFFER Dissolving 3.4gm in 500 ml Water adjust pH 3.0 with H3PO4
Mobile Phase Prepare a mixture Buffer and Acetonitrilel in the
Ratio (40:60). Filter through 0.45micron
Standard Preparation : Weight accurately 50 mg Losartan Potassium WS into 50ml .
volumetric Flask make up with 0.1 N NaOH. Dilute 5.0ml of the
Solution to 50.0 ml make up with mobile phase.
Weight accurately 62.5mg Hydrochlorothiazide in 50 ml volumetric
Flask make up with 0.1N NaOH.Dilute 1.0ml of this solution 50 ml
volumetric flask make up with mobile phase.
Test Preparation :Weigh and powder 20.0 tablets . Weight a quantity of powder containing
50.0 mg Losartan Potassium and 12.5 mg Hydrochlorothiazide in
50.0ml volumetric flask make up with 0.1N NaOH. Dilute 5.0ml of this
solution into 50ml volumetric flask make up with mobile Phase.
Calculation for Losartan Potassium and Hydrochlorothiazide
Au =Average area of major peaks due to Losartan Potassium and
obtained with Test preparation.
As= Average area of major peaks due to Losartan Potassium l and
P =Potency of Losartan Potassium l and Hydrochlorothiazide WS.