Development and Validation of a Stability-Indicating HPLC Method for Determination of Bromocriptine Mesylate in Bulk Drug and Tablets

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.

Development and Validation of Analytical Method for Qualitative and Quantitative Determination of Glibenclamide in Different Brands of Tablet Dosage form Using UV-Visible Spectroscopy

“…Final volume was made up to obtain the final concentration 100 µg/ml of GLB. An appropriate aliquot portion of GLB solutions (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 and 5 ml) from the standard stock solution of GLB was transferred to 10 ml volumetric flasks and methanol was added in all flasks to obtain the final concentration of 5,10,15,20,25,30,35,40,45 and 50 µg/ml of GLB. All the solutions were scanned separately between 200 nm to 400 nm in UV-visible spectrophotometer and λ max for GLB was recorded.…”

“…Till now, various methods have been developed and validated for the analysis of various anti-diabetic agents [9][10][11][12][13][14][15]. High quality of the active ingredient in final pharmaceutical dosage form is very important and it needs a simple, accurate, precise and fast method for the qualitative and quantitative estimation of active ingredient in its specific pharmaceutical dosage form [16][17][18][19][20]. Among various analytical methods, UV-visible spectrophotometric method fulfills these demands and it may be the instrumental technique of choice for the analysis of active pharmaceutical ingredients in industrial and as well as laboratory scale [21,22].…”