Dissolution Profiling for Generic Solid Dosage form

We are doing Hydroxychloroquine Sulfate   200 mg tablet Dissolution profile V/s Plaquenil 200 mg Tablet. The drug has very high solubility ratio.We start profiling with 500 ml volume, Apparatus II,50 RPM,37 degree in Buffer: pH 1.0 – 1.2 (usually 0.1 N HCl or SGF without enzymes), pH 4.5, and pH 6.8. In pH4.5 and 6.8 buffers we achieved dissolution >85% within 15 min. In pH 1.2 for generic formulation dissolution not achieved >85% within 15 min although innovator found okay. So i would like here guidance for how to proceed further. Should i go for increased volume of 750 ml or 900 ml only for pH 1.2 buffer with 75 RPM with both Test and innovator. Can anyone guide me in such cases, how to proceed for this as this study is needed for biowaiver. I need to understand practical way to overcome this issue with regulatory compliance also.

Please need guidance for me.



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