In-vitro study of quality control parameters of three different brands of azithromycin tablets

Rashmi Singh, Monika Saxena, Deeksha Sahay, Sujata Singh


Background: Azithromycin, being a very important antibiotic, is manufactured by different pharmaceutical companies and available in numerous brands. Therefore, it requires a quantitative evaluation and assessment of tablets chemical, physical and bioavailability properties.

Methods: The physicochemical quality pararametrs like weight variation, size, hardness, friability, disintegration time and dissolution profile of three brands of azithromycin tablets were assessed by performing various test procedures according to established methods.

Results: The different brands of tablets showed very slight variations in weight and size, not exceeding more than 5% of standard value. Similarly, hardness of all the brands was less than 5kg/f and friability ranged from 0.2 to 0.5%. All the brands tested disintegrated in <6 minutes and all the brands released >75% of the active ingredient within 45 minutes.

Conclusions: All the physiochemical quality parameters of three brands of azithromycin tablets were found to be within the pharmacopeial specifications therefore all the brands were pharmaceutically and chemically equivalent and can be freely interchanged.


Azithromyin, Disintigration time, Dissolution test, Friability, Hardness

Full Text:



Mac Dougall C, Chambers HF. Protein synthesis inhibitors and miscellaneous antibacterial agents. Brunton LL, Chabner BA, Knollmann BC. Goodman and Gilman's: The Pharmacological Basis of Therapeutics. 12th Ed. New York, Mc Graw-Hill; 2011:1529-1530.

Trivedi HK, Patel MC. Development and validation of a precise LC method for the determination of drug release during dissolution profile in pharmaceutical formulation. Int J Chem Tech Res. 2010;2(2):912-9.

Hoepelman IM, Schneider MM. Azithromycin: the first of the tissue-selective azalides. Int J Antimicrob Agents. 1995;5(3):145-67.

Zuckerman JM, Qamar F, Bono BR. Review of macrolides (azithromycin, clarithromycin), ketolids (telithromycin) and glycylcyclines (tigecycline). Med Clin North Am. 2011;95:761-91.

Sivakumar R, Venkataraman PE, Natarajan R, Ganeasn V, Ashrafali KA. Comparative in vitro evaluation of commercial aceclofenac tablets. Int J Chem Sci. 2009;7(3):1591-4.

Awofisayo O, Oladoja A, Awofisayo N. Comparative assessment of the quality control measurements of multisource ofloxacin tablets marketed in Nigeria. Disso Tech. 2010;6:20-5.

Nayak AK. Comparative in vitro dissolution assessment of some commercially available paracetamol tablets. International Journal of Pharmaceutical Sciences Review and Research. 2010;2(1):29-30.

Adegbolagun O, Ololade OA, Osamah SE. Comparative evaluation of the biopharmaceutical and chemical equivalence of some commercially evaluable brands of ciprofloxacin hydrochloride tablets. Trop J of Pharm Res. 2007;6:737-45.

Chow S. Pharmaceutical validation and process controls in drug development. J Drug Info. 1997;31:1195-201.

Jakaria M, Mousa AY, Parvez M, Zaman R, Arifujjaman, Sayeed MA, et al. In vitro comparative study of different brands of dexamethasone tablet available in Bangladesh. Int J of Pharma Qual Assur. 2016;7(2):24-8.

Dittert LW. American pharmacy, An introduction to pharmaceutical techniques and dosage forms. 7th Ed. Philadelphia; 1974:308-383.

The Indian Pharmacopoeia, Government of India, Ministry of health and family welfare, Controller of publication, New Delhi. 2007;1:63-5.

Kumar D, Singh J, Antil M, Kumar V. Quality control of tablets: A review. Int J of Uni Pharm and Bio Sci. 2016;5(4):53-67.

Amin R, Biswas S, Rahman R, Rana S. Study and impact evaluation of particle size distribution on physicochemical properties of three different tablet formulations through sieve technology. Int J for Pharm Res Sch. 2014;3(1):448-63.

Giri TK, Manjusha. Comparative In Vitro Evaluation of Conventional Ibuprofen Marketed Formulation. Journal of Pharma SciTech. 2013;2(2):75-80.