ABSTRACT

A simple, economical, precise, and accurate reverse phase high-performance liquid chromatography (RP- HPLC) method has been developed and validated to estimate teneligliptin and rosuvastatin in a tablet dosage form. A RP-HPLC analysis was performed on ECO-C18 5? (15mm*4.6mm*5? (particle size) column with using mobile phase buffer pH 6.8: ACN 75:25 (v/v) and 1 ml of triethylamine at 280 nm detection wavelength with the flow rate of 1.0 mL/min. The analytical method was validated as per International Council for Harmonization (ICH) guidelines. The linearity was observed in the Limit of Quantitation (LOQ)- 0.258 ?g/ml range for teneligliptin. Similarly, the LOQ-0.129 ?g/ml range was observed linearity for rosuvastatin. The Limit of Detection (LOD) value was found to be 0.853 ?g/mL for teneligliptin and 0.427 ?g/mL for rosuvastatin. The correlation coefficient was 0.99 for both teneligliptin and rosuvastatin. The %recovery value was found to be a minimum of 100.27% and a maximum of 101.64% for teneligliptin. Similarly, the %recovery value was found to be a minimum of 100.31% and a maximum of 101.60% for rosuvastatin. The relative standard deviation value for repeatability, interday precision, and intraday precision was less than 2%. Forced degradation studies was also applied to these drugs in a various condition like acidic, basic, oxidation, thermal and photolytic. During stability studies, it was found thatTeneligliptin is degraded more in oxidative condition (11.33%) and Rosuvastatin in acidic condition. (20.31%). The proposed method was found to be specific, sensitive, precise, accurate, and robust in nature Keywords: Teneligliptin, Rosuvastatin, stability indicating RP-HPLC method, validation
Publication date: 01/07/2024

https://ijbpas.com/pdf/2024/July/MS_IJBPAS_2024_8171.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.7.8171