ABSTRACT

An effortless, hasty, unambiguous, robust, exactas well as precise isocratic reverse phase high performance liquid chromatographic technique has been urbanizedin addition to validated for the assessment of Nateglinide in tablet dosage form. The chromatographic severance was accomplished on Phenomenex kinetex C18(250mm×4.6mm i.d, 5µm) column by means of a mobile phase mixture containing methanol: buffer of pH 6.8: ACN in the proportion of 47:23:30 respectively at a flow rate of 1ml/min with injection volume of 20µl and recognition wavelength of 216 nm at ambient temperature. The retention time was established to be 4.823mins by way of a run time of 7mins. The linearity was obtained in the range of 20 to 300µg/ml with correlation coefficient of 0.9996. The mean entitlement recuperation at every level was established to be within the limits of 98% and 105%.The optimized method was used to assay the pharmaceutical dosage form and assay value was found to be 96.94%. The anticipated technique was validated as per ICH guidelines as well as applied for the investigation of Nateglinide in tablet dosage form. Keywords: Nateglinide, Assay, RP-HPLC, Method development, Validation
Publication date: 25/09/2021

https://ijbpas.com/pdf/2021/September/MS_IJBPAS_2021_SEPT_SPCL_1040.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.9.1040