Abstract

Ciprofloxacin is a fluorinated 4-quinolone or fluoroquinolone antibacterial with a wider spectrum of activity than nalidixic acid and more favorable pharmacokinetics allowing its use in systemic infections. It has been used in the treatment of a wide range of infections. Many different brands and dosage forms of Ciprofloxacin hydrochloride are available in the Sana'a market that places health practitioners in a dilemma of drug substitution in case of non-availability of a particular brand.
 The aim of the present study was to evaluate the quality control of five brands of Ciprofloxacin hydrochloride tablets marketed and commonly prescribed in Sana'a city. The results and findings of the present study will be interpreted and discussed.
 Five brands of Ciprofloxacin hydrochloride tablets (500 mg) were purchased from the retail pharmacy outlets and their pharmaceutical quality were assessed by using in-vitro tests as per the British Pharmacopoeia (BP) and unofficial standards as recommended by the manufacturers. The assessment of tablets included the evaluation of uniformity of weight, friability, hardens, disintegration time, dissolution test and assay content by UV spectrophotometric method. All brands passed USP and BP standards in- vitro quality control tests prescribed for the tablets except hardens test but the all products were satisfactory for hardness.
 The results indicated that the overall quality of all tested Ciprofloxacin hydrochloride tablets brands was satisfactory as they met the requirements of the official and unofficial quality control tests.

Highlights

  • Quality control is all measures designed to ensure the output of uniform batches of drugs that conform to established specifications of identity, strength, purity, and other characteristics[4]

  • All brands were studied through the evaluation of weight variation, drug content, hardness, friability, disintegration time and dissolution profile

  • Percentage friability was calculated as: Disintegration Test Six tablets from each brand were employed for this test in a freshly prepared medium, 0.1N HCl at 37oC using the British Pharmacopoeia (BP) disintegration apparatus

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Summary

INTRODUCTION

Ciprofloxacin is a synthetic flouroquinolone derivative with broad spectrum antibacterial activity[1]. It is widely used in the treatment of urinary tract infections, lower respiratory tract infections, bacterial diarrhoea, skin and soft tissue infections, bone and joint infections, gonorrhea, and in surgical prophylaxis[2]. Quality control is all measures designed to ensure the output of uniform batches of drugs that conform to established specifications of identity, strength, purity, and other characteristics[4]. Drugs that are chemically and biopharmaceutically equivalent must be identical in strength, quality, and purity. The content uniformity, disintegration, and dissolution rates must be comparable[7]. The aim of the present study is to evaluate the quality of different brands of Ciprofloxacin tablets

MATERIALS AND METHODS
RESULTS AND DISCUSSION
CONCLUSION
Tripathy KD
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