PHYSICOCHEMICAL AND ANALYTICAL STUDIES OF THE MICRO DETERMINATION OF MUSCLE RELAXANT DRUGS IN PURE FORM AND ITS PHARMACEUTICAL PREPARATIONS

Abstract

The quality of phannaceutical products is commonly expressed as an amount of active ingredient (measured by some assay procedure) compared with the amount that is claimed to be present. For some products, where there is possibility of toxic substances related to the active ingredient being present, additional tests may be carried out to ensure that they are not present beyond acceptable limits<'l. These tests do not, however, give any indication of the cause of poor quality. A batch of any formulated product may be assayed for active ingredient and filler because appreciably less than the stated amount of drug is present. This result does not tell the analyst why this poor quality was observed. The drug may have degraded due to adverse storage conditions or inappropriate processmg conditions; the raw material used for manufacture of the batch may have been impure; or the manufacture may have inadvertently of deliberately produced the formulation containing the incorrect amount of active ingredient, which may point to poor quality assurance during the manufacture, or to counter feting. Drug analysis IS under taken during vanous phases of

pharmaceutical development, such as formulations and stability studies, quality control, toxicological and pharmacological testing in animals and human<2 1 In hospitals, drug analysis is performed on patients sample in support of clinical trials (pharmacokinetic and bioavailability studies) and in monitoring therapeutic drugs and drugs of abuse<I-S) All these investigations require reliable and validated analytical methods in order to