fa مروری کوتاه بر اعتبارسنجی روش آنالیز با استفاده از تکنیک HPLC شیمی مواد غذایی پژوهشي Research <span style="font-size:12px;"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="line-height:107%"><span sans-serif=""><b><span lang="FA"><span style="line-height:107%"><span b="" zar="">چکیده</span></span></span></b></span></span></span></span><br> <span style="direction:rtl"><span style="unicode-bidi:embed"><span style="line-height:107%"><span sans-serif=""><span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">کروماتوگرافی</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">مایع با عملکرد بالا</span></span></span> <span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">(HPLC)</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">به دلیل کارایی استثنایی و حساسیت بالا در تشخیص</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">آنالیت</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">مورد نظر،</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">به‌عنوان</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">تکنیک جداسازی</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">مورد ‌توجه</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">در آنالیزهای دارویی و زیست پزشکی مدرن شناخته شده است. در حوزه</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">تجزیه ‌و‌تحلیل</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">نمونه‌های</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">دارویی، نتایج بدست آمده باید قابل اعتماد باشند. بنابراین</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">اعتبار‌سنجی</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">روش‌های</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">آنالیز،</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">مرحله‌ای</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">اساسی در فرایند</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">توسعه‌ی</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">آن‌ها</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">می‌باشد</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">که اثبات</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">می‌کند</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">این</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">روش‌ها</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">برای اهداف مورد نظرشان مناسب و قابل اعتماد هستند. پایگاه‌های داده شامل </span></span></span><span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">PubMed</span></span></span><span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">، </span></span></span><span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">PubMed Central</span></span></span><span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">، </span></span></span><span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">Google Scholar</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">و</span></span></span>&nbsp;<span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">ICH Q2R2</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">با استفاده از کلمات کلیدی شامل </span></span></span>&nbsp;<span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">HPLC</span></span></span><span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">، </span></span></span><span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">Validation</span></span></span><span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">، </span></span></span><span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">Accuracy</span></span></span><span style="line-height:107%"><span b="" zar=""> و</span></span> <span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">Precision</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">مورد بررسی قرار گرفتند. برای تامین الزامات تعیین شده توسط</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">دستورالعمل‌های</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">شرایط بهینه تولید</span></span></span> <span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">(GMP)</span></span></span><span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">،</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">شرکت‌های</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">دارویی موظف به</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">برنامه‌ریزی</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">به‌منظور</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">نظارت و بررسی تمامی</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">فرآیند‌های</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">خود هستند. هدف اصلی از این کار، اثبات استاندارد بودن تمامی</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">فرآیند‌های</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">صنعت اعم از توسعه، ساخت، تولید و</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">روش‌های</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">آنالیز</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">می‌باشد</span></span></span><span dir="LTR"><span style="line-height:107%"><span b="" zar="">.</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">هدف از نگارش این</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">مقاله‌ی</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">مروری ارائه راهکاری برای انجام</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">مطالعه‌ی</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">اعتبارسنجی</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">روش‌های</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">آنالیز مورد استفاده در صنعت داروسازی</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">می‌باشد</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">که</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">به‌ویژه</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">بر روی</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">دستورالعمل‌های</span></span></span>&nbsp;<span dir="LTR"><span style="line-height:107%"><span new="" roman="" times="">ICH</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">در این زمینه متمرکز شده است. در این</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">دستورالعمل‌ها،</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">پارامتر‌هایی</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">نظیر صحت، دقت، اختصاصی بودن، خطی بودن نتایج،</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">محدوده‌ی</span></span></span> <span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">کاری، حد تشخیص، حد</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">اندازه ‌گیری </span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">و استحکام روش آنالیز بررسی</span></span></span>&nbsp;<span lang="AR-SA"><span style="line-height:107%"><span b="" zar="">شده‌اند.</span></span></span></span></span></span></span></span><span style="font-size:11pt"><span style="direction:rtl"><span style="unicode-bidi:embed"><span style="line-height:107%"><span sans-serif="" style="font-family:Calibri,"><span lang="FA" style="font-size:12.0pt"><span style="line-height:107%"><span style="font-family:"B Zar""></span></span></span></span></span></span></span></span> <div style="text-align: justify;"><span style="font-size:12px;"><span style="line-height:107%"><span sans-serif=""><b><span style="line-height:107%"><span new="" roman="" times="">Abstract</span></span></b></span></span><br> <span style="line-height:107%"><span sans-serif=""><span style="line-height:107%"><span new="" roman="" times="">High-performance liquid chromatography (HPLC) is recognized as a primary separation technique in modern pharmaceutical and biomedical analyses due to its exceptional efficiency and high sensitivity in detecting the analyte of interest. In the analysis of pharmaceutical samples, it is essential to ensure the reliability of the produced results. Method validation is a critical stage in the development of analytical methods, determining whether these methods are suitable and reliable for their intended purposes.&nbsp;The databases including PubMed, PubMed Central, Google Scholar, and ICHQ2R2 were searched using keywords such as HPLC, Validation, Accuracy, and Precision.&nbsp;To meet the requirements set by Good Manufacturing Practice (GMP) guidelines, pharmaceutical companies must establish a program to monitor and evaluate all their processes. The primary goal of this effort is to standardize all processes involved in the industry, including development, manufacturing, production, and analytical methods.&nbsp;This review article aims to provide insightful guidance on conducting validation for analytical methods that employed in pharmaceutical analysis. Specifically, it focuses on the validation process as per ICH Guidelines, which encompasses a comprehensive evaluation of performance characteristics such as accuracy, precision, specificity, linearity, working range, limit of detection, limit of quantification, robustness.</span></span></span></span></span></div> &nbsp; اعتبارسنجی,HPLC,صحت,دقت HPLC,Accuracy,Precision,Validation 11 22 http://amfi.ir/browse.php?a_code=A-10-177-1&slc_lang=fa&sid=1 Amir Beheshti Maal امیر بهشتی مآل amirbeheshtimaal@gmail.com 1003194753284600731 1003194753284600731 No Department of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Tehran Medical Sciences, Islamic Azad University (IAUPS), Tehran, Iran گروه شیمی دارویی، دانشکده داروسازی، دانشگاه علوم پزشکی آزاد اسلامی تهران Seyed Mohammad Alavi سید محمد علوی beactive90@gmail.com 1003194753284600732 1003194753284600732 No Department of Pharmaceutical Chemistry, Faculty of Pharmacy and Pharmaceutical Sciences, Tehran Medical Sciences, Islamic Azad University (IAUPS), Tehran, Iran گروه شیمی دارویی، دانشکده داروسازی، دانشگاه علوم پزشکی آزاد اسلامی تهران Hoda Jahandar هدی جهاندار ho_jahandar@yahoo.com 1003194753284600733 1003194753284600733 Yes Department of pharmacognosy, Faculty of Pharmacy and Pharmaceutical Sciences, Tehran Medical Sciences, Islamic Azad University (IAUPS), Tehran, Iran گروه گیاهان دارویی، دانشکده داروسازی، دانشگاه علوم پزشکی آزاد اسلامی تهران