DEVELOPMENT AND VALIDATION OF TITRIMETRIC METHOD FOR ESTIMATING POTENCY OF DRUG 5-BENZYL 1, 2, 3, 4- TETRAHYDRO-2-METHYL ? CARBOLINE NAPHTHALENE 1, 5 DISULPHONATE
Yogesh Chandra Nainwal*
ABSTRACT
The drug development is a long process and the nonaqueous titrations play vital role in drug development via monitoring the synthesis of drug intermediates and finally the drug itself. Mebhydrolin Napadisylate is an H1- receptor blocking antihistamine drug which is white powder and odourless in physical state. It is used in Hay fever, Rhinitis, Urticaria, Angioedema, Eczema and other allergic conditions. Mebhydrolin forms a salt with 1, 5 Naphthalene disulphonic acid (Napadisylic acid) to give rise to Mebhydrolin Napadisylate. The potency of drug is monitored by performing nonaqueous titration against perchloric acid using crystal violet as indicator. The method gives reliable results with least labour. The method is cost effective since high instrumentation is no more required in this method. The accuracy of the method was evaluated in total fifteen replicates as intraday and interday analysis taking three different concentrations within range of Mebhydrolin Napadisylate. The ruggedness and recovery study was also carried out to ascertain the reliability of the method.
Keywords: Nonaqueous Titration, Mebhydrolin Napadisylate, Perchloric acid.
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