Abstract

Stability indicating RP-UPLC method for the determination of Aliskerin and its impurities in its bulk and pharmaceutical dosage forms.

Author(s): Srihari Molleti, Vinay Rao and K. N. Jayaveera

A reversed-phase liquid chromatography (RP-UPLC) method is validated for the determination of aliskiren in tablet dosage form. The LC method is carried out on a Waters Acquity, BEH, C8 column (100 × 2.1 mm i.d.), maintained at 25°C. The mobile phase consisted of 2.72 grams of potassium dihydrogen ortho phosphate and 3.5 grams of 1- Octane sulfonic acid adjusted to pH 2.0 as aqueous phase and Acetonitrile as organic phase with gradient programme, run at a flow rate of 0.5 mL/min, with photodiode array detector set at 230 nm. The chromatographic separation is obtained with aliskiren retention time of 3.70 min, and it is linear in the range, with R2 values greater than 0.9999. The specificity and stability-indicating capability of the method are proven through degradation studies, which also showed that there is no interference of the formulation excipients, showing that peak is free from any co eluting peak. The method showed adequate precision, with a relative standard deviation (RSD) values lower than 2.0%. Good values of accuracy were also obtained, with a mean value of 90-110%. Experimental design is used during validation to calculate method robustness. The proposed method is applied for the analysis of bulk drugs and the tablet dosage forms, contributing to improve the quality control and to assure the therapeutic efficacy.

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