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Determination of Sibutramine in herbal slimming products available in local market by TLC and HPLC

تحري وجود السيبوترامين في المستحضرات النباتية المُنحفة المنتشرة في السوق المحليّة باستخدام تقنيتي الـTLC و الـHPLC

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 Publication date 2016
  fields Pharmacy
and research's language is العربية
 Created by Shamra Editor




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Herbal slimming products are one of the most wide spreading herbal products in many countries around the world and in Syria as well, they are often advertised to contain purely natural ingredients. These products are provided by various sources and they are available over the counter, therefore, in most cases, they are not under quality control. Such these quality-uncontrolled products are considered a health and economic issue facing many countries in the world especially undeveloped countries which usually lack for regulation rules governing herbal products trading. In this study, 20 samples have been collected from the herbal slimming products available in the local market. At the beginning, these samples have been divided into locally manufactured samples (8 samples) and illegal samples (12 samples). The packaging and labeling test has been applied to all samples. Later on, these samples have been tested with TLC and HPLC to make sure they are free of Sibutramine, using in TLC Methanol/Toluene (1:9) as a mobile phase, and in HPLC Acetonitrile/phosphate buffer pH=5.5 (70:30) as a mobile phase, column BDS Hypersil C18, flow rate 0.5 ml/min and wavelength 225nm. The results of packaging and labeling test revealed that all of the locally manufactured samples are matching to the American pharmacopoeia USP30 and GMP in terms of packaging, labeling and internal leaf sheets with exception for one sample. As for illegal samples, all of them matched the pharmacopoeia and GMP with exception for 6 samples. With regards to testing the samples using TLC and HPLC, results indicated that 3 samples out of 8 locally manufactured samples contained Sibutramine with amount ranging between (8- 10) mg/capsule, while all illegal samples contained Sibutramine with amount ranging between (5-26) mg/capsule.


Artificial intelligence review:
Research summary
تُعنى هذه الدراسة بتحري وجود مادة السيبوترامين في المستحضرات النباتية المُنحفة المنتشرة في السوق المحلية السورية باستخدام تقنيتي الكروماتوغرافيا السائلة عالية الأداء (HPLC) والكروماتوغرافيا الطبقية الرقيقة (TLC). تم جمع 20 عينة من هذه المستحضرات، منها 8 عينات مُصنعة محليًا و12 عينة غير شرعية. أظهرت النتائج أن 3 عينات من المستحضرات المحلية تحتوي على السيبوترامين بكمية تتراوح بين 8-10 ملغ/الكبسولة، بينما جميع العينات غير الشرعية تحتوي على السيبوترامين بكمية تتراوح بين 5-26 ملغ/الكبسولة. الدراسة أكدت على ضرورة مراقبة هذه المستحضرات لضمان خلوها من المواد الكيميائية غير المصرح بها والتي قد تشكل خطرًا على الصحة العامة.
Critical review
دراسة نقدية: تعتبر هذه الدراسة خطوة مهمة في تسليط الضوء على مشكلة التدليس الدوائي في المستحضرات النباتية المُنحفة، إلا أن هناك بعض النقاط التي يمكن تحسينها. أولاً، حجم العينة المدروسة صغير نسبيًا، مما قد يؤثر على دقة النتائج. ثانياً، لم تتطرق الدراسة إلى تأثيرات السيبوترامين الصحية بشكل مفصل، وهو جانب مهم يجب أخذه بعين الاعتبار. ثالثاً، كان من الأفضل تضمين توصيات أكثر تحديدًا حول كيفية تحسين الرقابة على هذه المستحضرات. على الرغم من هذه النقاط، فإن الدراسة تقدم معلومات قيمة حول وجود السيبوترامين في المستحضرات النباتية المُنحفة وتدعو إلى ضرورة تعزيز الرقابة الدوائية.
Questions related to the research
  1. ما هي التقنية المستخدمة لتحليل وجود السيبوترامين في المستحضرات النباتية المُنحفة؟

    تم استخدام تقنيتي الكروماتوغرافيا السائلة عالية الأداء (HPLC) والكروماتوغرافيا الطبقية الرقيقة (TLC) لتحليل وجود السيبوترامين في المستحضرات النباتية المُنحفة.

  2. كم عدد العينات التي تم جمعها في هذه الدراسة؟

    تم جمع 20 عينة من المستحضرات النباتية المُنحفة في هذه الدراسة.

  3. ما هي كمية السيبوترامين التي تم العثور عليها في العينات غير الشرعية؟

    تراوحت كمية السيبوترامين في العينات غير الشرعية بين 5-26 ملغ/الكبسولة الواحدة.

  4. ما هي التوصيات التي خلصت إليها الدراسة؟

    أوصت الدراسة بضرورة متابعة الدراسة على عدد أكبر من الخلطات والمستحضرات النباتية المُنحفة، والتأكد من خلو المستحضرات المُنحفة من مواد كيميائية أخرى، ومراقبة مستحضرات نباتية أخرى مثل المستحضرات الخافضة لسكر الدم والمقوية جنسيًا والمنومة، والتأكد من خلوها من أي مواد كيميائية مُضافة بشكل غير شرعي.


References used
Ariburnu, E., Uludag, M., Yalcinkaya, H., Yesilada, E. Comparative determination of Sibutramine as an adulterant in natural slimming products by HPLC and HPTLC densitometry. Journal of pharmaceutical and biomedical analysis, 2012, volume 64(65), 77-81
Bhatia, Lav., Thumar, K., Tanna, R. Determination of adulteration of anti-obesity drug in Indian herbal medicinal product: Development and validation of analytical method. Pharma analysis and Quality Assurance, 2012, Volume 3, 177-182
Chong CSY. Psychosis related to the use of Sibutramine disguised as Over-the-counter herbal weight loss remedies: a report of two patients. East Asian Arch psychiatry, 2010, Volume20, 186-189
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