Stability Indicating UPLC Method Development and Validation for the Quantification of Ibandronate Sodium and Characterisation of its Degradation Products

In the present study a new stability indicating UPLC method has been developed and validated for the quantification of Ibandronate sodium. The developed method was validated as per ICH guidelines. The parameters which are validated are linearity, accuracy, precision, robustness and system suitability parameters. The chromatographic conditions were optimized before the development of the chromatogram. The mobile phase consisted of a mixture of pH 5.3 ammonium formate buffer and acetonitrile (70:30 v/v) under under isocratic mode of elution. The system suitability parameters such as theoretical plates, tailing factor and peak symmetry were determined to check the validity of the developed UPLC method. The developed chromatographic method proved to be superior to most of the reported methods in terms of accuracy, precision and sensitivity. The data obtained was subjected to statistical analysis. The proposed method was successfully applied to the determination of the selected drug in its pharmaceutical dosage form. The stability indicating UPLC method is useful to understand the degradation behaviour of Ibandronate sodium. Ibandronate sodium was subjected to forced degradation study. IBT was found to degrade in thermal degradation conditions and the degradation product was characterised by Mass spectrometry. Toxicity of the degradation product was checked by using Osiris software. It was found that the degradation product is non-toxic. Prediction results are colour coded in which the red colour shows high risks with undesired effects like mutagenicity or poor intestinal absorption and green colour indicates drug-conform behaviour. The proposed method is accurate, selective, sensitive and reproducible. The method is relatively free from any interference produced from common tablet excipients. Hence, the recommended procedure is well suited for the assay and evaluation of IBT in pharmaceutical quality control. The present work can be extended for the quantification of the selected drug in bioavailability, bioequivalence, pharmacokinetics, in-vitro and in-vivo correlation studies. A successful analyst must know what reactions are taking place during analysis and be able to understand and apply the theory upon which the method is dependent. The analyst must acquire skills of technique, patience, neatness and accuracy. Absolute integrity is demanded of every quantitative analyst. To become a successful analyst, one must realize that, analytical chemistry is not a simple routine procedure. Manipulative skill acquired by experience with the ability to follow directions under the supervision of a skilled analyst may enable one to carry out successfully certain analytical procedures