"Development and Validation of a Rp-HPLC Method for the Analysis of Rimantadine Hydrochloride in Medicinal Form"

Abstract

The aim of the research work was to conduct precolumn derivatization of Rimantadine hydrochloride (RMT) with Anthraquinone -2 -sulphonyl chloride (AQSC) to develop a validated, selective, precise and accurate RP-HPLC -UV method for the analysis of RMT -AQSC derivative in its Medicinal form. The isocratic mobile phase for the C -18 column consisted of Ethylnitrile and 0.005M 1 -octane sulfonic acid sodium salt monohydrate buffer (pH adjusted to 6.7) in 60:40 volume ratio. Flow rate maintained at one millilitre in one minute at ambient temperature. The ideal UV detection wavelength for RMT derivative was 259 nm. The retention time for both API and the medicine was 6.79 minutes. Linearity was satisfied over a range of 50 ppm to 250 ppm with a correlation coefficient (r) value 0.999. Percentage RSD for precision, accuracy and robustness were less than 2. The LOD and LOQ were 1.32 ppm and 4.0 ppm respectively. Validation was done as per 1CH guidelines and all the results were with in the limits.

Development and validation of HPLC method for simultaneous determination of rimantadine marketed product

“…The validation of analytical methods is crucial in drug development to ensure the reliability, accuracy, and robustness of the methods used to analyze pharmaceutical compounds. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines provide a framework for the validation of analytical procedures, encompassing parameters such as specificity, linearity, accuracy, precision, and robustness [20]. Validation studies are essential for demonstrating that the analytical methods are suitable for their intended purpose, whether it is the quantification of active pharmaceutical ingredients in medicinal products, the determination of drug content in pharmaceutical formulations, or the analysis of drug levels in biological fluids for pharmacokinetic evaluations.…”