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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ASSAY DETERMINATION OF SECNIDAZOLE IN FORMULATED PRODUCT BY RP-UPLC

Abhilasha Sinsinwar, Bharti Tapeesh, Dr.S. S.Sisodia

Abstract


Objective: to develop and validate a new very rapid, sensitive, reverse phase Ultra Performance Liquid Chromatography (RP-UPLC) technique for the estimation of Secnidazole in dosage form, as there is no official monograph & no analytical method by UPLC. Methodology: Chromatographic separation was achieved on a Waters Acquity BEH C18 column (30 x 2.1 mm, 1.7μm) using a gradient method with mobile phase composed of Ammonium acetate5 mM and acetonitrile in the ratio 98:2 v/v. The flow rate was 0.3 ml/min, temperature of the column was maintained at ambient and detection was made at 210 nm. The run time was as short as 2.5 min. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. Results: The developed method was linear for Secnidazole from 100 - 600 μg/ml and the linear regression obtained was > 0.99. Precision, evaluated by intra- and inter-day assays had relative standard deviation (R.S.D) values within 0.62 %. Recovery data were in the range 98.48 to 108.42%. Conclusion: The method is precise, accurate, linear, robust and fast. The short retention time of 1.24 min allows the analysis of a large number of samples in a short period of time and, therefore, should be cost-effective for routine analysis in the pharmaceutical industry.

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