1. The impurity of diuretic hydrochlorothiazide 04, also be a medical intermediate.
2. It’s mainly used for the detection of drug impurities, the synthesis of hydrochlorothiazide and the screening of medical structural fragments.
3. Presents a weak alkaline,refrigeration.
. Recommended Products is: 5250-72-6 and 22503-72-6.
A stability-indicating RP-HPLC method has been developed and validated for simultaneous determination of Valsartan & Hydrochlorothiazide and their impurities in FDC (Fixed Dose Combination) tablet dosage form. The method was developed using L1 column (250 ¡Á 4.6 mm; 5 ¦Ìm) with gradient elution using the mobile phase consisting of solvent-A (0.1% Ortho phosphoric acid) and solvent-B (100% Acetonitrile); the gradient program (Tmin/%B) was set as 0/10, 5/10, 20/60, 40/60, 41/10 and 50/10. The eluted compounds were monitored at 265 nm. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The influence of Acid, Alk., Oxidative, Photolytic, Thermal and Humidity stress conditions, on drug product was studied. The limit of quantification results of Valsartan, Hydrochlorothiazide and their impurities are, VAL: 0.303 ¦Ìg/mL, HCTZ: 0.019 ¦Ìg/mL, VAL RC-B: 0.085 ¦Ìg/mL, VAL RC-C: 0.327 ¦Ìg/mL, HCT RC-A: 0.017 ¦Ìg/mL, CTZ: 0.080 ¦Ìg/mL and 5-Chloro HCT: 0.047 ¦Ìg/mL. The proposed method is suitable for the estimation of Valsartan & Hydrochlorothiazide impurities in tablets dosage form.
Stability indicating RP-HPLC method for quantification of impurities in valsartan and hydrochlorothiazide FDC tablet dosage form. Recommended basis is hydrochlorothiazide 20. Products is: https://www.ambeed.com/products/742-20-1.html, 432499-63-3
Referemce:
Benzoxazole – Wikipedia,
Benzoxazole | C7H5NO – PubChem