Development and validation of TLC-densitometry method for simultaneous quantification of Montelukast sodium and Levocetirizine dihydrochloride pharmaceutical solid dosage form

By Smita Sharma, M. C. Sharma, D. V. Kohli, A. D. Sharma


In this study, validated high performance thin liquid chromatographic (HPTLC) method for estimation of have been developed and validated for the simultaneous determination of Montelukast and Levocetirizine in combined pharmaceutical formulation. The chromatography estimation was performed using the following conditions: stationary phase was precoated silica gel 60 F254  aluminum sheets (10 x 10 cm, E. Merck) and the mobile phase used was chloroform: methanol: toluene: glacial acetic acid (10:5:3:0.5 v/v/v/v). Chromatogram was developed in a camag twin trough chamber using a linear ascending technique. The method was validated in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 400 to 4500 ng with regression coefficient of 0.9998.The proposed method can be successfully used to determine the drug content of marketed tablet formulation.


Key Words : Montelukast, Levocetirizine, HPTLC, densitometry estimation


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