Validated HPTLC Method for Simultaneous Estimation of Levocetirizine Hydrochloride and Nimesulide in Formulation

This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous estimation of levocetirizine hydrochloride and nimesulide as the bulk drug and in tablet dosage forms. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of toluene: ethyl acetate: methanol: ammonia 9: 1: 1: 0.5(v/v/v/v). Densitometric evaluation of the separated zones was performed at 238 nm. The two drugs were satisfactorily resolved with RF values 0.21 ± 0.02 and 0.26 ± 0.02 for levocetirizine and nimesulide, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (100–350 ng/spot for levocetirizine and 400-1400 ng/spot for nimesulide), precision (intra-day RSD 1.03–1.41 % and inter-day RSD 1.10–1.85 % for levocetirizine, and intra-day RSD 0.07–0.25 % and inter-day RSD 0.28–0.75 % for nimesulide), accuracy (100.06 ± 1.16 % for levocetirizine and 99.48 ± 0.50 % for nimesulide), and specificity, in accordance with ICH guidelines.

Author(s): Sunil R. Dhaneshwar, Kumudini S. Rasal, Vidhya K. Bhusari, Janaki V. Salunkhe and Amruta L. Suryan

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