Journal
ORIENTAL JOURNAL OF CHEMISTRY
Volume 32, Issue 2, Pages 777-788Publisher
ORIENTAL SCIENTIFIC PUBL CO
DOI: 10.13005/ojc/320203
Keywords
Valsartan; hydrochlorothiazide; Central Composite Design; Design of experiments (DoE); Analytical Quality by Design (AQbD); Response surface methodology (RSM); HPLC
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The present paper involves the analytical quality by design (AQbD)-based development of a simple, rapid, accurate and precise stability-indicating method for the estimation of valsartan and hydrochlorothiazide. Optimized mobile phase (v/v/v) was water (containing 0.25 ml/L triethylamine), methanol and acetonitrile (50:38:37, pH adjusted to 3.0 +/- 0.1). Chromatographic separation was achieved on Hypersil (R)-Gold C-18 (150 x 4.6 mm, 5 mu m, Thermo Fisher Scientific, USA), column at 25 +/- 2 degrees C. The method was validated as per the International Conference on Harmonisation (ICH) guidelines. Chromatographic run time was 10.0 minutes. The linearity range for valsartan and hydrochlorothiazide were 1.25-64.00 mu g/ml and 0.195-10.00 mu g/ml respectively. The limits of detection (LOD) for valsartan and hydrochlorothiazide were 0.253 and 0.0226 mu g/ml while the limits of quantitations (LOQ) were 0.767 and 0.068 mu g/ml respectively, using 10 mu l sample. Stability studies indicate that the degradation of valsartan was higher during oxidative stress than other stress conditions.
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