Quality Control Evaluation and In - vitro Equivalence of Various Brands of Marketed Azithromycin Tablets

Azithyromcin an antmicrobial medication, and belongs to a new class of azalide antimicrobials that belongs to the macrolide group of S50 protein inhibitors. Continuous monitoring of pharmaceutical products is vital because it is important for human health, Azithromycin recently more used effectively for treatment of lower and upper respiratory tract gram-negative and may gram-positive organisms in cases of resistance to anther antibiotics used for these diseases. A set of physicochemical and microbiological tests and quality control tests using the modified constitutional chromatography method to assessment Azithromycin tablets quality of various national Syrian brands and compared to reference international band (Azicip ®), the results of these tests showed that acceptable limit so can be used safely with suitable cost. The results of tests that used for evaluation; uniformity of weight, hardness, friability, and microbial assay. Their results ranged between ;651 mg to 902.5 mg, 14.91±0.42 to 19.58±0.43 (Kg/cm2), 0.02 to 0.5%, 94.18 to 98.32%, (mean ± S.D) respectively. All tablets disintegrated within 3.8 to 8 minutes with distilled water. The dissolution (%) in 0.1 N HCL and phosphate buffer solution pH = 6.0 at 37.0 ± 0.5 °C after 45 minutes was between 87% to 92% by using HPLC device. The results of assay were (99.4 %, 97.8 %, 98.6 %, 97.4 %) of A, B, C of local companies and D of reference company respectively, these results were acceptable according to USP Pharmacopeia limit. The validation of the analytical method was verified in which, the value of limit of detection (LOD) was 0.0933 μg/ml, the value of limit of quantification (LOQ) was 0.311 μg/ml, correlation coefficient R value was 0.9998 that indicated the linearity of applied method within the range of concentration (27.25-132.14 %).