ABSTRACT

A stability indicating reverse phase high performance liquid chromatographic method has been developed and validated for estimation of Metolazone in its bulk and formulation. Method development was carried out on Hypersil BDS C18 column, (150×4.6mm, particle size 5?). The chromatographic separation was achieved using a mobile phase containing acetonitrile and HPLC water in the ratio of 50:50 v/v at flow rate of 0.7 ml/min using detection at 236 nm. Linearity was performed from 1-10 ?g/ml with correlation coefficient of 0.999. The LOD and LOQ for the method were found to be 0.1?g/ml and 0.3?g/ml respectively. The statistical analysis shows that the method was found to be accurate, reliable, simple and reproducible. The % RSD for precision is NMT 2%. The chromatographic retention time of proposed method was 3.5 min. The percentage purity of Metolazone was found to be within the limit. For stability studies, the drug was exposed to the stress conditions such as acid, alkaline, oxidation, thermal by using 0.1 M HCl, 0.1 M NaOH, 3.0% H2O2, 80º C. Degradation behavior shows that the major degradation was observed at acidic condition (89.6%) followed by oxidation (90.1%), alkaline (91.9%), and thermal (94.5%). The proposed method was successfully applied for the quantitative determination of Metolazone in bulk and pharmaceutical dosage form. Keywords: RP-HPLC, Metolazone, Validation, Forced degradation studies
Publication date: 01/03/2020

https://ijbpas.com/pdf/2020/March/MS_IJBPAS_2020_4990.pdf

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https://doi.org/10.31032/IJBPAS/2020/9.3.4990