Abstrakt

Avalidated HPLC method for determination of ibandronate sodium residue in cleaning validation byRI detector

Subasranjan Acharya, C.Srinivasulu, Sopan Shintre, Rautray Hemant

A high performance liquid chromatography (HPLC) method has been developed and validated for the quantitative determination of trace amount of Ibandronate Sodium (IBN) residue in pharmaceutical equipment. A new, generic method is presented for detection and estimation of a potent compound IBN, with which it is possible to verify the cleaning process of equipment used in pharmaceutical manufacturing. The chromatographic separation was performed on anAllsep anion column with a particle size of 7µ (150X4.6) and 0.2% v/v formic acid adjusted to pH 3.2 as mobile phase at flowrate of 1.2mL/minutes. The refractive index detector has been used for the determination of the compound with very poor UV detection. Sensitivity of the method is found to be satisfactory (LOQ value of the IBN is 3 µg mL-1) in RI detector for a compound with very poor UV absorbance and linear calibration curves were established over the concentration range 3– 60 µg mL-1.The method validation results indicated that the method is specific, accurate, linear and reproducible. The HPLC method is suitable for cleaning control assaywith goodmanufacturing practice (GMP) of pharmaceutical industry. . This method was also suitable for the assay determination of IBN in pharmaceutical dosage forms.