QUANTITATIVE ANALYSIS AND MONITORING OF ANTIBIOTIC DRUGS APPROVED AND AUTHORIZED FOR SALE IN THE REPUBLIC OF UZBEKISTAN

ABSTRACT

This study presents a detailed investigation of the quantitative analysis and continuous monitoring of antibiotic drugs that are approved and authorized for sale in the Republic of Uzbekistan. In recent years, the issue of antibiotic resistance and the need for strict quality control have become increasingly important. The aim of the study was to evaluate the content uniformity and compliance of several commonly used antibiotics using High-Performance Liquid Chromatography (HPLC).

The research was performed using a Shimadzu Nexera LC-40 HPLC system with SPD-M40 UV detector to analyze Azithromycin, Erythromycin, and Ciprofloxacin in tablet dosage forms. Calibration curves, validation parameters, and assay results were calculated in accordance with pharmacopeial guidelines. The results indicated that the quantitative content of the antibiotics ranged between 96.5% and 100.2%, demonstrating compliance with the pharmacopeial limits (95–105%).

These findings highlight the necessity of continuous pharmaceutical quality control and monitoring programs to ensure patient safety and effective antimicrobial therapy within Uzbekistan and the broader Central Asian region.

АННОТАЦИЯ

В данной работе представлен подробный анализ количественного определения и мониторинга антибиотиков, утвержденных и разрешенных к продаже в Республике Узбекистан. В последние годы проблема антибиотикорезистентности и необходимость строгого контроля качества лекарственных средств приобрели особую актуальность. Целью исследования являлось определение количественного содержания и соответствия требованиям фармакопеи наиболее распространённых антибиотиков методом ВЭЖХ.

Для анализа использовалась система Shimadzu Nexera LC-40 с УФ-детектором SPD-M40. Объектами исследования служили таблетки азитромицина, эритромицина и ципрофлоксацина, реализуемые на фармацевтическом рынке Узбекистана. Проведены построение калибровочных графиков, оценка параметров валидации и количественного содержания. Полученные результаты показали, что содержание действующих веществ находилось в пределах 96,5–100,2%, что соответствует требованиям фармакопеи (95–105%).

Результаты подчеркивают важность проведения регулярного фармацевтического мониторинга качества антибиотиков для обеспечения безопасности пациентов и предотвращения формирования устойчивости микроорганизмов в регионе Центральной Азии.

Keywords: Antibiotics, HPLC, Quantitative analysis, Uzbekistan, Drug monitoring, Pharmaceutical quality

Ключевые слова: Антибиотики, ВЭЖХ, Количественный анализ, Узбекистан, Мониторинг лекарств, Контроль качества

Introduction

Antibiotics are among the most significant discoveries in medical history and are essential in the treatment and prevention of bacterial infections. Their widespread use, however, has also led to one of the major health challenges of the 21st century — antimicrobial resistance (AMR). The World Health Organization (WHO) reports that antibiotic misuse and poor-quality medicines are among the leading causes of AMR development.

In Uzbekistan, the pharmaceutical sector is rapidly expanding, and the government pays special attention to the regulation of antibiotic distribution and production. Despite these efforts, the quality of antibiotics circulating in the domestic market may vary due to storage conditions, counterfeit products, and inconsistencies in manufacturing standards. Therefore, quantitative analysis and regular monitoring are essential components of ensuring the safety and therapeutic efficacy of antibiotics used in healthcare institutions.

The objective of this research is to perform a detailed quantitative analysis of three commonly used antibiotics in tablet form — Azithromycin, Erythromycin, and Ciprofloxacin — using HPLC. These antibiotics were selected based on their frequency of prescription in Uzbekistan and Central Asia. The study also aims to compare the obtained data with pharmacopeial standards and discuss the role of analytical control in ensuring rational antibiotic therapy.

Materials and Methods

Sample Preparation

For the experimental analysis, commercially available antibiotic tablets were purchased from authorized pharmacies in Andijan region. Each sample was labeled with its manufacturing and expiration date, and the integrity of the packaging was verified before testing. The tablets were powdered, and accurately weighed portions equivalent to 500 mg of active ingredient were dissolved in the mobile phase.

Chromatographic Conditions

The analyses were performed using a Shimadzu Nexera LC-40 system equipped with an SPD-M40 UV-VIS detector. The separation was achieved on a C18 analytical column (250 × 4.6 mm, 5 μm) maintained at room temperature. The mobile phase consisted of acetonitrile and phosphate buffer (60:40 v/v), filtered and degassed before use. The flow rate was set at 1.0 mL/min, and the injection volume was 20 µL. Detection wavelengths were 210 nm (Azithromycin), 215 nm (Erythromycin), and 278 nm (Ciprofloxacin) respectively.

Calibration and Validation

Calibration curves were constructed using five concentration levels of each standard solution. The correlation coefficients (R²) were greater than 0.999, confirming good linearity. Precision and accuracy were evaluated by repeated injections of standard solutions. The method validation followed ICH Q2(R1) guidelines, ensuring that the analytical procedure was both reliable and reproducible.

Results and Discussion

Table 1.

The quantitative results are summarized

The obtained results indicate that all three antibiotics complied with pharmacopeial specifications. Azithromycin and Ciprofloxacin showed excellent uniformity, while Erythromycin presented slightly lower content values, possibly due to its lower stability in ambient conditions.

The findings were compared with data from similar studies conducted in Kazakhstan and Kyrgyzstan, which also reported assay values between 95–102%. The consistency of results across the Central Asian region suggests that the manufacturing quality of these antibiotics remains stable within acceptable pharmacopeial limits.

Additionally, chromatographic profiles of each antibiotic were well-defined, with retention times consistent with standard references. The relative standard deviation (RSD) for replicate injections was less than 1.5%, confirming the method’s precision. These results demonstrate the suitability of HPLC for routine quality control of antibiotic preparations.

Regular monitoring of marketed drugs allows early detection of substandard or degraded products. Implementing national antibiotic quality surveillance systems could significantly improve pharmaceutical safety and help control the spread of antimicrobial resistance.

Conclusion

The present study confirmed that the tested antibiotics available in the Uzbek pharmaceutical market meet pharmacopeial quality requirements. The application of HPLC proved to be a reliable, sensitive, and reproducible method for quantitative analysis and quality assessment of antibiotic drugs.

Ongoing monitoring and cooperation between regulatory agencies, manufacturers, and analytical laboratories are essential for maintaining the high quality of pharmaceutical products. It is recommended that such analyses be expanded to include other antibiotic classes, such as cephalosporins and penicillins, to provide a more comprehensive understanding of the antibiotic quality landscape in Uzbekistan.

These results emphasize that quantitative analysis is not only a laboratory task but also a public health priority, ensuring safe and effective use of antibiotics in medical practice.

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