Analytical Method Development and Validation of Nicorandil by HPLC

Nicorandil is Anti-anginal drug. There are several methods like HPLC, LC-MS, Ultraviolet Spectroscopy etc. are available for the estimation of Nicorandil in biological fluids and pharmaceutical dosage form.we could not trace Single HPLC Method with short Retention Time (RT). So to develop and validate a HPLC method for the estimation of Nicorandil in Pharmaceutical with the retention time around 5 min. HPLC method for estimation of Nicorandil in its dosage form was developed. The developed HPLC method was validated for specificity, linearity and range, accuracy, method and intermediate precision, robustness, system suitability and applied to pharmaceutical formulation and the %Assay of Nicorandil Tablets was found to be in the range of 98-102%. For developing HPLC technique for analysis of Nicorandil tablet. Numbers of trials were taken for selection of column, mobile phase. The developed method was validated as per ICH guideline. The advantages of chromatographic techniques were higher accuracy, small sample size and less consuming, however it requires costly HPLC grade solvents and availability of HPLC instrument. This method can be successfully applied for the estimation.

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