A validated GC method for estimation of process related impurities in 3-(N-methyl-N-pentylamine) propionic acid hydrochloride (ISB), a precursor of ibandronate sodium

The present paper describes the development of a gas liquid chromatographic method for advanced intermediate of Ibandronate sodium (ISB) in the presence of its impurities. As the molecule is a hydrochloride salt, the sample preparation was critical for the quantification of known and unknown impurities. Successful separation of ISB from the synthetic impurities achieved on aAT-5, 30 m × 0.53 mm, 5µ column. The developed GC method was validated with respect to linearity, accuracy, precision, ruggedness and robustness. To the best of our knowledge, a validated GC method which separates all the impurities disclosed in this investigation was not published elsewhere.