A validated stability indicating ion exchange chromatographic method for the quantification of alendronate, phosphite and phosphate in alendronate sodium tablets and analysis of in-vitro dissolution samples

• P Sunil Reddy ^[1] ; K Sudhakar Babu ^[2] ; Navneet Kumar ^[1] ; P Balakrishna ^[1]
  1. [1] Dr. Reddy's Laboratories
  2. [2] S. K. University Department of Chemistry
• Localización: Journal of the Chilean Chemical Society (Boletín de la Sociedad Chilena de Química), ISSN-e 0717-6309, ISSN 0366-1644, Vol. 57, Nº. 3, 2012, págs. 1232-1234
• Idioma: inglés
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• Resumen

  • A stability-indicating LC method was developed on ion exchange chromatography equipped with refractive index detector for the quantification of phosphite, phosphate content and assay of alendronic acid in pharmaceutical dosage forms. The isocratic separation was achieved by using Allsep anion (150mm x 4.6mm) 7 µm column with mobile phase containing a 5.3 mM formic acid, pH adjusted to 3.5 with sodium hydroxide solution at a flow rate of 1.2 mL/min. Alendronate sodium was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Alendronate sodium was found to degrade significantly in oxidative stress conditions only. The developed method was extensively validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision and robustness. The developed LC method was successfully applied for analysis of in-vitro dissolution samples of marketed alendronate sodium tablets.