Abstract
A simple, rapid and sensitive RP-HPLC method was developed and validated for the quantification of bromocriptine mesylate in bulk drug and tablet formulation. The separation was achieved on a Zorbax Eclipse XDB-C18 column (150 mm x 4.6 mm i.d.). The mobile phase consisted of methanol and 20 mM sodium acetate, pH 5 (70:30, v/v) at a flow rate of 1.5 mL min-1 and detection was performed at 300 nm using photodiode array (PDA) detector. The drug was subjected to various ICH prescribed stress conditions including hydrolysis (neutral, acid and alkaline), oxidation, photolysis and thermal degradation. The drug in solution was found to degrade significantly in alkaline hydrolysis and when exposed to sunlight. The proposed method was validated with respect to specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), stability, and robustness as per ICH guideline. The peak purity achieved from PDA detector and satisfactory resolution between drug and its degradants established the specificity of the method. The developed method was found to be successively applied for the quality control of bromocriptine mesylate in bulk drug and tablets as well as the stability indicating studies.
Keywords: Bromocriptine mesylate, Bulk drug, Forced degradation, RP-HPLC, Stability-indicating method, Tablets, Validation, LOQ, LOD, acid
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