Comparison of Physico-Chemical Parameters of Different Brands of Fluconazole Tablet Marketed in Pakistan

The standard of pharmaceutical products is very important matter of concern in appropriate management and achievement of therapeutic goals of therapy. After manufacturing pharmaceutical products underwent for standard tests that are required to confirm the standard of product. These tests are either physical or chemical performed according to United States of Pharmacopeia (USP), to assure the standard of product. Nowadays, each drug is manufactured by several pharmaceutical companies, with different prices but following same standard. In developing countries standard and price of product is always matter of concern. Therefore, research was designed on comparative analysis of fluconazole tablets used most commonly for the treatment of fungal infection. The objective of research was to analyze the quality of commercially available brands of fluconazole in terms of physicochemical parameters, evaluate and compare the active concentration and determine the appropriateness of their interchangeability. For current research four brands of fluconazole tablets having strength of 150 mg were selected and purchased from local market. Research on fluconazole tablets were completed within one year from 5-6-2017 to 5-6-2018. Different physical and chemical tests were performed by taking USP as standard. Results of comparative study on fluconazole tablets on different brands were obtained and compared with standard. Each tablet of all four brands of Fluconazole pass the aesthetic test. All four brands pass the weight uniformity test. All 10 tablets of four brands pass the thickness, diameter and hardness test and meets the standard criteria. In friability test F-01, F-02 and F-04 brands pass the test, whereas F-03 brand (2.1%) fail the friability test. All 6 tablets of four brands pass the disintegration and dissolution test and meets the standard criteria. Assay was performed on high performance liquid chromatography (HPLC) and result shows that F-01, F-02 and F-03 brands pass the assay test, whereas F-04 brand (73.91%) fail the test and contains the lower concentration of active than allowed limit. It was concluded that fluconazole brands F-01 and F-02 passes the all quality control test and meet the standard, whereas F-03 brands fail in friability test, whereas brand F-04 fail in assay test. It was recommended that three brands of Fluconazole (F-01, F02, and F-03) are pharmaceutically and therapeutically equivalent and can be used interchangeably.