ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING STUDIES OF SECNIDAZOLE IN API & PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC TECHNIQUE

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K. Faiza Firdos
L. Siva Sanker Reddy
R. Nageswara Rao
S. Muneer
N. Madana Gopal
N. Yella Subbaiah
Shaik Ruksar
K. Maheshwari
C. Madhsudhana Chetty

Keywords

Secnidazole, Methanol, OPA, HPLC, ICH Guidelines, Secnil

Abstract

The project was aimed at developing an analytical method to quantify Secnidazole drug either alone or in tablet formulation, including stability studies with the aid of RP-HPLC technique. An analytical method was finalised and inspected consistency of the method by performing the different validation parameters like system suitability, specificity, linearity, accuracy, precision, LOD, LOQ, Robustness and assay. The degradation studies were performed under different physical and chemical conditions by following the ICH guidelines. The column used was Inertsil ODS Column C18 (4.6×250mm)5µm of Shimadzu.


 


The HPLC was Shimadzu make with UV PDA detector and model 20AD. In the stream lining the analytical method, we have settled on to use the mobile phase with the combination of Methanol: 0.1% OPA (90:10 v/v). The drug was detected at 314 nm on UV-Visible spectrophotometer. The retention time was at 2.953 min with the run time of 10 min. The linearity range of Secnidazole was from 2 µg/ml to 10µg/ml and the Regression coefficient calculated to be (R2) 0.999. The corresponding recognition limits (LOD and LOQ) of the Secnidazole was 0.3µg/ml and 0.9µg/ml respectively. Precision studies were carried out and the RSD values were found to be less than two. The degradation studies were successfully conducted. The significant advantages were reduction of retention time at 1ml/min and the mobile phase used was quite cheaper than the reported methods. The other part was that, the usability of the method to quantify even though the drug was degraded nearly to 10 % in presence of the unknown degradants. The method is also sensitive, reproducible, quick and economical.

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