Development and validation of hptlc method for simultaneous estimation of aceclofenac and pregabalin in bulk dossage form

Author: 
Rajendra B. Patil,. Tushar A. Deshmukh and Vijay R.Patil

The present study reports simultaneous estimation of Aceclofenac and Pregabaline. A new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of Aceclofenac and Pregabaline in bulk and in formulation. Chromatographic separation was performed on aluminum plate precoated with Silica Gel 60 F254 using Toluene: Methanol: Formic acid (7: 3: 0.2 v/v/v) as the mobile phase with saturation time 20 min, followed by densitometric scanning at 210 nm. This system was found to give compact spot for Aceclofenac and Pregabaline (Rf value = 0.68 ± 0.03 and 0.27 ± 0.03 respectively) and specificity in accordance with international conference on harmonization (ICH) prescribed stress conditions. The calibration curve of Aceclofenac was found to be linear between 100-600 ng/band whereas Pregabaline was found to be linear between 75 - 450 ng/band. The % mean recovery found to be of Aceclofenac 99.67 ± 1.92 and Pregabaline is 100.80 ± 1.08. The limit of detection of Aceclofenac 19.53 ng/ band and Pregabaline 15.87 ng/band, whereas limit of Quantitation were found to be of Aceclofenac 59.17 ng/band and Pregabaline is 48.10 ng/band, respectively. The proposed method was found to be accurate, precise, reproducible, specific and sensitive and applicable for the determination of Aceclofenac and Pregabaline in bulk and in formulation. The drug was subjected to stress condition of hydrolysis (acid, base and neutral), oxidation, photolysis and thermal degradation.

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