Validation of RP-HPLC Method for the Estimation of Timolol Maleate in Fast Dissolving Tablets

Author(s)	Gurpreet Singh, R.K Dhawan
Country	India
Abstract	A simple, precise and reproducible validation method was develop for Timolol Maleate as per ICH (International Council for Harmonization) guidelines Q2R(1) and subsequently stability indicating method as per ICH guidelines Q1A(R2). Chromatographic evaluation was carried out on C18 column of Agilent (25 cm x 4.6 mm), (i.d. 5 µm.) with a mobile phase consist of Methanol : Water (20:80 v/v). Flowrate was maintained to 0.8ml/min. The stability indicating data revealed that Timolol Maleate was found to be unstable alkaline condition. The validated method was applied various validation parameters like Linearity(calibrationcurve),Precision, Accuracy,Robustness,LOD and LOQ were found to be 0.9μg/ml and 2μg/ml. The validated method can be used for estimation of Timolol Maleate in prepared Fast DissolvingTablets (FDTs) by using Croscar mellose Sodium(CCS) as a superdisintegrant a calculated their optical parameters.
Keywords	Timolol Maleate, RP-HPLC, Stability Studies, FDTs
Field	Chemistry > Pharmacy
Published In	Volume 6, Issue 2, March-April 2024
Published On	2024-03-09
Cite This	Validation of RP-HPLC Method for the Estimation of Timolol Maleate in Fast Dissolving Tablets - Gurpreet Singh, R.K Dhawan - IJFMR Volume 6, Issue 2, March-April 2024. DOI 10.36948/ijfmr.2024.v06i02.13862
DOI	https://doi.org/10.36948/ijfmr.2024.v06i02.13862
Short DOI	https://doi.org/gtmbk7

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