Determination of nelfinavir mesylate as bulk drug and in pharmaceutical dosage form by stability indicating HPLC.

摘要

A isocratic, selective, accurate and stability indicating HPLC method of analysis of nelfinavir mesylate both as a bulk drug and in formulations was developed and validated. A CN chromatographic column (250 mmx4.6 mm, 5 microm) was used for the separation at 40 degrees C. The mobile phase consisted of a mixture of acetonitrile (MeCN) and 25 mM monobasic ammonium phosphate (containing 25 mM triethylamine, pH 3.4 with phosphate acid) (40:60, v/v) was delivered at a flow rate of 1.0 ml/min with detection at 210 nm. The developed method was validated in terms of selectivity, linearity, limit of quantitation, precision, accuracy and solution stability. As the proposed LC method achieved satisfactory resolution between nelfinavir mesylate, its degradation products, intermediate product possibly present in nelfinavir drug substance and other impurities in the end product before refining in the final step of synthetic process, it can be employed as a stability indicating one, used for the synthetic process control and determination of nelfinavir mesylate in pharmaceutical preparations.