Analytical method development and validation of aliskiren in bulk and tablet dosage form by RP- HPLC method

Swamy, G. Kumara; Rao, J. V. L. N. Sheshagiri; Kumar, J. M. Rajendra; Kumar, U. Ashok; Bikshapathi, D. V. R. N.; kumar, D. Vinay
March 2011
Journal of Pharmacy Research;Mar2011, Vol. 4 Issue 3, p865
Academic Journal
A simple, accurate, precise, and reproducible reverse phase liquid chromatographic method developed and validated for the quantification of Aliskiren in bulk drug and in Pharmaceutical dosage form. Separation was achieved under optimized chromatographic condition on a PhenomenaxLunaC18 (ODS) column (150 × 4.6 mm i.d., particle size 5m). The mobile phase consisting of phosphate buffer pH 3.0: Acetonitrile (60:40, v/v). An isocratic elution was achieved at a flow rate of 1 ml/ min at ambient temperature. The detection was carried out at 293nm using Shimadzu UV-Visible detector SpD-10AVP. The retention time of Aliskiren was found to be 5.02 min. The calibration curve was linear in the concentration range of 5-30mg/ ml (r2- 0.9999).The limit of detection and the limit of quantification were found to be 0.580531 mg/ml and 1.75918mg/ml respectively. The amount of Aliskiren present in the formulation (Tekturna) was found to be 99.79 ± 0.8075. The method was validated statistically using the SD, %RSD and SE and the values were found to be within the limits. The recovery studies were performed and the percentage recoveries were found to be 101.10±1.635%. So, the proposed method was found to be simple, specific, linear, and rugged. Hence it can be applied for routine analysis of Aliskiren in bulk and pharmaceutical formulation.


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