DEVELOPMENT AND VALIDATION OF A NEW AND STABILITY INDICATING LC METHOD FOR ANALYSIS OF PINAVERIUM BROMIDE IN BULK DRUG AND PHARMA- CEUTICAL DOSAGE FORM
ABSTRACT A simple, rapid, and stability indicating reverse phase high performance liquid chromatographic assay method was developed for pinaverium bromide in the presence of its degradation products generated from decomposition studies.LC separation was achieved isocratic mode on a Zorbax SB C8 (4.6x250) mm, 5 µm column using mobile phase containing solution A (0.1% ortho phosphoric acid) with solution B (acetonitrile) (30:70) (v/v) at flow rate 1.0 ml/min. The UV detector was operated at 245 nm and temperature was 25˚C. The retention time was 4.84 min and linearity was observed in the concentration range of 20-150µg/ml with correlation coefficient of 0.9999. The percentage relative standard deviation in accuracy and precision studies was found to be less than 2%. The method was successfully validated as per International Conference on Harmonization (ICH) guidelines. pinaverium bromide undergoes degradation under acidic, basic, oxidation, dry heat and photolytic conditions, degradation impurities did not interfere with the retention time of pinaverium bromide, and assay method is thus stability indicating
