Validation and application of a modified RP-HPLC method for the quantification of midazolam in pharmaceutical dosage forms.
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Date
2011-01
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Abstract
The purpose of the study was to develop a simple, sensitive and rapid RP-HPLC
method for the determination of Midazolam in marketed products. Chromatographic
determination was performed in a reverse phase C18 column (250 mm × 3.3 mm I.D. , 5μm
particle size) using a mixture of acetonitrile: methanol: 0.065 M ammonium acetate buffer
(50:20:30, v/v/v), final pH adjust to 5.5 ± 0.02 with ortho phosphoric acid as mobile phase and
delivered at a flow rate of 1 ml/min. The UV detection was set at 220 nm. The calibration range
was from 2.0 to 30.0 μg/ml. The method was validated in term of linearity (r2>0.98, RSD=
1.958%), precision (RSD=3.757 %) and accuracy. The limit of quantification was 2 μg/ml and the
limit of detection was 0.1 μg/ml. The potency of midazolam in marketed products was
determined by this method with acceptable precision and reproducibility.
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Keywords
Midazolam, marketed products, RP-HPLC, development of a method
Citation
Desai Sapna, Vidyasagar Gali, Desai Dhruv. Validation and application of a modified RP-HPLC method for the quantification of midazolam in pharmaceutical dosage forms. International Journal of Applied Biology and Pharmaceutical Technology. 2011 Jan-Mar; 2(1): 411-416.