A particle size distribution method was developed and validated for rabeprazole sodium by using laser diffraction technique. The determination of the particle size was carried out by using wet measurements. The dispersant consisted of light liquid paraffin oil with a refractive index as 1.430. The particle refractive index was set at 1.54 and stirrer speed was set at 2000 rpm with absorption value of 0.1 and obscuration of 15%. The developed method was further validated statistically by evaluating the instrumental parameters like stirrer speed, obscuration, particle refractive index, dispersant refractive index, sonication time, volume of dispersant, vortex time, sample concentration and validation parameter like repeatability. The particle size distribution i.e. diameter of 90% particles d(0.9) of rabeprazole was found to be < 50 µm. The method has been successfully used to analyze active pharmaceutical ingredient rabeprazole sodium with good reproducibility.
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