ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF BUPIVACAINE AND MELOXICAM IN SYNTHETIC MIXTURE
AbstractBupivacaine and Meloxicam are used in combination for treatment of Pain relief. Objective of present work was to develop simple, precise, accurate methods for simultaneous estimation of both drugs using HPTLC and RP-HPLC method. In HPTLC method silica gel G- F254 TLC plate as a stationary phase and a mobile phase of Toluene: Ethyl acetate: Methanol: Formic acid (6:2:1.5:0.5 v/v/v/v) used to resolve Bupivacaine and Meloxicam. Bupivacaine and Meloxicam were estimated at 270nm. The proposed method was validated according to ICH guideline Q2 (R1). For RP-HPLC method, chromatographic separation was achieved on Shim – Pack solar C18 (250 mm × 4.6mm, 5μm). Detection was carried out at 210nm using Acetonitrile:Methanol: Water pH-5, adjusted with 0.1% OPA (80: 10: 10 v/v/v). HPTLC method was found to be linear over the concentration range of 2000-6000ng/b and for BUP and 60-180 ng/band for MEL. HPLC method was found to be linear over the concentration range of 30-70μg/ml for BUP and 0.9-2.1μg/ml for MEL. All the methods were validated for linearity, precision, accuracy, LOD and LOQ according to ICH guideline Q2 (R1). All the method was accurate and precise.
Article Information
14
3066-3080
1077 KB
9
English
IJPSR
H. Bhavsar Jhanvi * and M. Desai Shuchi
Department of Pharmaceutical Quality Assurance, Dr. Chunibhai Vallabhbhai Patel College of Pharmacy, UTU, Bardoli, Surat, Gujarat, India.
jhanvibhavsar13@gmail.com
01 May 2025
03 October 2025
26 October 2025
10.13040/IJPSR.0975-8232.17(11).3066-80
01 November 2025
Download