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Method Development and Validation of Aliskiren Hemifumarate and Valsartan in bulk drug by RP-HPLC method
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A new simple, accurate, rapid and precise isocratic High Performance Liquid Chromatographic (HPLC) method was developed and validated for the determination of Aliskiren Hemifumarate (ALSK) and Valsartan (VAL) in bulk drug. The Method employs Waters HPLC system on C8 Column (4.6 x 250 mm, 5 μm) and flow rate of 1 ml/min with a load of 10μl. The Detection was carried out at 220 nm. mobile phase used as Acetonitrile and Phosphate buffer and Methanol was used as mobile phase in the composition of 45:40:15 , phosphate buffer (0.02Mm) adjusted the pH to 4 with Orthophosphoric acid within a short runtime of 8 min. The retention times of Aliskiren (ALSK) was 3.407 min, Valsartan (VAL) was 4.268 min. The method was validated according to the regulatory guidelines with respect to specificity, precision, accuracy, linearity and robustness etc.
Keywords
Aliskiren Hemifumarate, Valsartan, HPLC, Validation
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