Volume 6

January-March 2014

Validation and stability indicating RP-HPLC method for the determination of strontium ranelate API in pharmaceutical formulations

B R C Sekhar Reddy, Nallagatla Vijaya Bhaskar Rao

Abstract:
The present study describes the development and subsequent of a stability indicating RP-HPLC method for the analysis of Strontium Ranelate. The samples separated on an Inertsil C18 column by isocratic run using Methanol: Water: Acetonitrile 25:25:50(v/v/v) mobile phase with a flow rate of 1.1ml/min, and the determination wavelength was 239nm for analysis of Strontium Ranelate. The described method was linear within range of 10-70μg/ml (r2 = 0.999). The precision, ruggedness and robustness values were also within the prescribed limits (< 1% for system precision and < 2% for other parameters). Strontium Ranelate was exposed to acidic, basic, oxidative and thermal stress conditions and the stressed samples were analyzed by the proposed method. Chromatographic peak purity results indicated the absence of co eluting peaks with the main peak of Strontium Ranelate, which demonstrated the specificity of assay method for estimation of Strontium Ranelate in presence of degradation products. The proposed method can be used for routine analysis of Strontium Ranelate in quality control laboratories

Keywords: RP-HPLC, Strontium Ranelate, Validation, Stability Indicating Assay, Forced Degradation.