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Development And Validation of Stability Indicating Rp- Hplc Method for Simultaneuos Estimation of Cephalexin and Clavulanic Acid


Article Information

Title: Development And Validation of Stability Indicating Rp- Hplc Method for Simultaneuos Estimation of Cephalexin and Clavulanic Acid

Authors: Khushbu Maru, Darshit Ram, Sheetal Buddhadev

Journal: Journal of Neonatal Surgery

HEC Recognition History
Category From To
Y 2023-07-01 2024-09-30
Y 2022-07-01 2023-06-30

Publisher: EL-MED-Pub Publishers

Country: Pakistan

Year: 2025

Volume: 14

Issue: 26S

Language: en

Keywords: force degradation and validation

Categories

Abstract

The combined dosage form of cephalexin and clavulanic acid was tested using a stability- indicating RP-HPLC technique. The combined dosage form of cephalexin and clavulanic acid was tested using a stability-indicating rp-hplc technique.The measurement wavelength was found to be 228 nm. Linearity, accuracy, precision, robustness, LOD, and LOQ have all been verified for the approach. The concentration ranges of 62.5–187.5 μg/ml for clavulanic acid and 37.5–112.5 μg/ml for cephalexin were found to be linear. Using sodium dihydrogen phosphate monohydrate buffer (pH:5.0 with OPA): methanol in a 65:35% v/v ratio as the mobile phase, the rp-hplc approach showed better separation and asymmetry on an Intersil OCD C18 (250 x 4 mm, 4 μm) packed column at a flow rate of 1 ml/min. It was discovered that the retention times for cephalexin and clavulanic acid were 4.216 and 2.189 minutes, respectively. Drug products were subjected to oxidation, photolytic, thermal, acid, and base degradation during a stability study using forced degradation. Under the specified stress conditions, cephalexin and clavulanic acid were shown to degrade by 7–10%. The devised method, which can be employed for simultaneous estimation of cephalexin and clavulanic acid in their tablet dose form, was straightforward, precise, and specific


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