International Journal For Multidisciplinary Research

E-ISSN: 2582-2160   •   Impact Factor: 9.24

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Stability - indicating rp-hplc method for antidiabetic drugs: development and validation in pharmaceutical formulation

Author(s) Mr. Mayur S Ingle, Prof. Dr. Balaji N Thakare, Prof. Dr. Kailash R Biyani
Country India
Abstract To identify nateglinide in tablet, a novel stability-indicating RP-HPLC method was created. Using Acetonitrile: Phosphate Buffer (70:30 v/v) pH 4.5 as the mobile phase and UV detection at 214 nm, the chromatographic separation was carried out on a C18 column. For the substances under study, favorable retention characteristics and satisfactory chromatographic peak symmetry were obtained under the suggested chromatographic conditions. According to ICH criteria, the validation experiments showed that the suggested method had a high degree of accuracy, precision, sensitivity, and resilience. The medications underwent oxidation, moist heat, dry heat, acidic and alkaline hydrolysis, and photodegradation tests. It can be regarded as a stability indicator because the forced degradation experiments' specificity verified that the approach could successfully separate the medicines even when their degradation products were present. The scope of this study was the development and validation of a reliable, rapid, sensitive, precise reversed-phase high performance liquid chromatography (RP-HPLC) method for the determination of nateglinide in drug substance.
Keywords Nateglinide, stability-indicating assay method, RP-HPLC, accuracy, precision, robustness, validation, force degradation studies
Field Medical / Pharmacy
Published In Volume 7, Issue 2, March-April 2025
Published On 2025-04-30
DOI https://doi.org/10.36948/ijfmr.2025.v07i02.43419
Short DOI https://doi.org/g9g77x
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