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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Development And Validation Of RP-HPLC Method For Estimation Of Olopatadine Hydrochloride And Ambroxol Hydrochloride In Their Synthetic Mixture

Author: MOSAM SHUKLA, RAGIN R SHAH, ALISHA P PATEL, DEEP P. PATEL
Abstract: Simple, precise, rapid, accurate, specific and sensitive reverse phase liquid chromatographic method has been developed for the estimation of Olopatadine hydrochloride and Ambroxol hydrochloride in their synthetic mixture. The wavelength maxima for Olopatadine hydrochloride and Ambroxol hydrochloride are 299.20 nm and 307.40 nm respectively. In the reversed phase liquid chromatographic method, estimation of Olopatadine hydrochloride and Ambroxol hydrochloride in their synthetic mixture was carried out using Lichrosphere C18 column (250 X 4.6mm, 5 µm). Mobile phase used, consisted of Methanol: Water: Triethylamine (0.1% v/v) in the proportion of 80:15:05, v/v/v and the pH of mobile phase was adjusted to 7.6 ± 0.05 using 0.5% v/v Orthophosphoric acid. The estimation was carried out at 237 nm using a UV detector keeping the flow rate of 1.0 ml/min and injection volume 20 µl. The proposed method was successfully utilized for the determination of Olopatadine hydrochloride and Ambroxol hydrochloride in their synthetic mixture, with good linearity, high percentage of recovery and acceptable precision. Different analytical validation parameters like linearity, accuracy, precision, limit of detection and limit of quantification were determined according to International Conference on Harmonization ICH Q2 (R1) guidelines.
Keyword: Olopatadine hydrochloride, Ambroxol hydrochloride, Reverse phase chromatographic method, Lichrosphere C18 column, Mobile phase, Wavelength maxima, ICH Q2 (R1) guidelines
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