Method Development and Simultaneous Estimation for Skeletal Muscle Relaxant in Solid Dosage Form Using Rp-HPLC
Key Points
The aim is to develop an RP-HPLC method for the simultaneous estimation of tolperisone hydrochloride and etodolac in solid dosage forms.
Developed a reversed-phase liquid chromatography method using a Grace C18 column.
Optimized mobile phase composition of Methanol: Buffer at 55:45 (v/v) with a flow rate of 1.4 ml/min.
Performed UV detection at 254 nm.
Retention times were 8.30 minutes for etodolac and 9.36 minutes for tolperisone.
The method demonstrated a linearity range of 10-50 µg/ml for etodolac and 2-10 µg/ml for tolperisone.
The limits of detection were 0.17 µg/mL for etodolac and 0.08 µg/mL for tolperisone, with recovery rates of 100.57% and 99.94% respectively.
Abstract
A reversed-phase liquid chromatography (RP-HPLC) method was developed for the simultaneous determination of tolperisone hydrochloride (TOLP) and etodolac (ETD) in a solid dosage form. The analysis was performed using a Grace C18 column. The optimal composition of the mobile phase was found to be Methanol: Buffer 55:45 (v/v). The flow rate was set at 1.4 ml/min and UV detection was carried out at 254 nm. Retention times of Etodolac 8.30 and Tolperisone (9.36). The method showed a good linearity range between 10-50ug/ml for etodolac and 2-10 ug/ml for tolpresione. The LOD was found to be 0.17µg/mL and 0.08µg/mL for Etodolac and Tolperisone respectively and LOQ was found to be 0.51µg/mL and 0.25µg/mL for Etodolac and Tolperisone respectively. % Recovery study for Etodolac and Tolpresione was found to be 100.57,99.94 respectively. The RSD for the precision of the method was found to be less than 2%.
Development of a Stability‐Indicating RP‐HPLC Method for the Quantification of Tolperisone Hydrochloride and Diclofenac Sodium Impurities in Drug Substances and in Combination: Implementation of Analytical Quality by Design and Degradation Kinetics2025 · 1 citations