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Stability indicating ultra-high performance liquid chromatographic assay of midazolam in bulk and dosage form

Author(s): A.K.Amruthraj | B.M.Venkatesha | S.Ananda

Journal: International Journal of Pharmacy and Biomedical Sciences
ISSN 0976-5263

Volume: 04;
Issue: 02;
Start page: 83;
Date: 2013;
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Keywords: Chromatographic separation | Forced degradation studies | UPLC method | Method validation

A stability-indicating reverse-phase ultra high performance liquid chromatographic (RP-UPLC) method has been developed for the determination of midazolam (MDZ) in bulk and dosage form. Chromatographic separations were carried out on Acquity UPLC BEH C-18 analytical column (100mm × 2.1mm i.d., 1.7µm) using a mobile phase consisting of acetonitrile-100mM disodium hydrogen orthophosphate and phosphoric acid buffer pH3.0 (35:65, v/v) at a flow rate of 0.3mL/min. The column temperature was maintained at 25°C. Quantitation was achieved with UV detection at 230nm based on peak area with linear calibration curves at concentration ranges 1-120µg/mL for MDZ (R2>0.9999). The method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation and robustness. This method has been successively applied to Mezolam® tablets and no interference from the tablet excipients was found. MDZ was exposed to acid (0.1N HCl), base (0.1N NaOH), oxidation (2%H2O2), dry heat (80°C for 2h) and photolytic (UV irradiation) stress conditions and the stressed samples were analyzed by the proposed method. As the proposed method could effectively separate the drug from its degradation products, it can be employed as stability-indicating method for the determination of instability of MDZ in bulk and commercial tablets.

Tango Jona
Tangokurs Rapperswil-Jona

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