VALIDATION OF STABILITY INDICATING RP-HPLC METHOD ANALYSIS FOR ASSAY OF AMISULPRIDE IN INJECTION
Ashlesha P. Bhagat*, Sonali S. Mahaparale and Reshma S. Kore
ABSTRACT
A simple and precise method was developed for the assay of
Amisulpride from injection formulation. The solvent system and
wavelength were optimized in order to maximize the sensitivity of the
proposed method; Amisulpride shows the maximum absorbance at 280
nm. The separation was achieved on RP-HPLC Isocratic system
equipped with HPLC Agilent 1200 series. The mobile phase was
prepared with buffer pH 4.5: Acetonitrile: Methanol in the ratio of
75:20:5 O-phosphoric acid used for the pH adjustment (pH-4.5). The
method was validated for accuracy, precision, linearity, specificity,
stressed studies, robustness, etc. Linearity was observed in the
concentration range of 70-130 % and gave mean correlation coefficient 0.999. The developed
RP-HPLC method was found to be accurate, precise and was successful applied to a
pharmaceutical injection formulation for qualitative estimation of Amisulpride.
Keywords: Amisulpride, RP-HPLC, Force degradation, method validation.
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