DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF VALSARTAN
Objective: A stability indicating RP-HPLC method was developed and validated for the determination of Valsartan using Telmisartan (10 Âµg/ml) as the internal standard.
Methods: In this procedure Phenomenex ODS C-18(250Ã—4.6 mm, packed with 5 micron) column was used with a new mobile phase consisting of methanol: acetonitrile: water (70:15:15 v/v) and the pH was adjusted to 3 by 0.1% glacial acetic acid with a flow rate of 1 ml/min. The eluents were monitored at 249 nm. Valsartan was subjected to stress conditions including hydrolytic degradation in acidic, basic and neutral conditions, oxidation, photolytic, UV degradation and thermal degradation.
Results: Linearity was obtained in the concentration range of 10-90 Âµg/ml (R2 =0.999) and with a regression equation y=0.074x+0.005. The LOD and LOQ values were 0.261 and 0.791 Âµg/ml respectively. The drug had shown promising degradation in the acidic, basic, neutral, thermal and oxidative stress conditions.
Conclusion: The method was validated for accuracy, precision, linearity, specificity and robustness and revealed that it is specific, accurate, rapid, precise, reliable and reproducible enough to analyze commercial dosage forms as per ICH guidelines.
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