A NEW STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES IN DORIPENEM MONOHYDRATE: BROAD-SPECTRUM CARBAPENEM ANTIBIOTIC DRUG
Sudhakar Yerra*, K. Mohana Naidu, B. Sreenivasulu, Hemant Kumar Sharma and B. Venkateswara Rao
ABSTRACT
A new stability indicating RP-HPLC method has been developed, optimized and validated for the determination of related substances in Doripenem monohydrate (DORIBAX) drug substance. Successful chromatographic separation of Doripenem monohydrate from its related substances, namely Doripenemic acid was achieved on octadecyl silane chemically bonded to silica particles stationary phase i.e. Inertstil ODS-3V, (250 x 4.6) mm, 5μm column, maintained at temperature 40°C by using phosphate buffer (pH 6.0±0.05) and acetonitrile in the ratio of 98:2 v/v as mobile phase-A and acetonitrile as mobile phase-B. UV detection: 230nm and 210nm for Doripenemic acid, flow rate: 1.0 ml/min and injection volume: 20μl. The proposed method is validated as per ICH guidelines in terms specificity, linearity, limit of detection (LOD) and limit of quantification (LOQ), precision, accuracy and robustness. Limit of detection of Doripenemic acid was 0.016(%w/w) indicating the high sensitivity of the developed method. The proposed method is useful in bulk drug analysis.
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