IZOTONIK KONSENTRATSIYANI VANT-GOFF, RAUL USULLARI VA NATRIY XLOR BO'YICHA EKVIVALENTI YORDAMIDA HISOBLASH: NAZARIY ASOSLAR VA FARMATSEVTIK AMALIYOT UCHUN VALIDATSIYA
DOI:
https://doi.org/10.5281/zenodo.20610335Keywords:
izotonik eritma, osmotik bosim, Vant-Goff tenglamasi, Raul qonuni, natriy xlor ekvivalenti, krioskopeik oʻzgarish, osmolallik, farmatsevtik validatsiya, parenteral eritmalar.Abstract
Ushbu tadqiqotda izotonik konsentratsiyani aniqlashning uchta asosiy usuli – Vant-Goff osmotik bosim tenglamasi, Raul muzlash nuqtasining pasayishi qonuni va natriy xlor boʻicha ekvivalent usuli – nazariy va eksperimental jihatdan qiyosiy oʻrganildi. Har uchala usul USP 43, BP 2024 va EP 11.0 talablari asosida validatsiya qilindi. Qon plazmasining fiziologik osmotik bosimi 780 ± 8 kPa (37 °C), krioskopeik oʻzgarish ΔTf = 0.52 °C va efektiv osmolallik 285–295 mOsm/kg ekanligini inobatga olgan holda, NaCl standart eritmasidan boshlangan hisoblash metodologiyasi ishlab chiqildi. Tekshirilgan 5 ta farmasevtik preparatda Vant-Goff usuli boʻicha topilgan osmotik bosim qiymatlari haqiqiy oʻlchangan qiymatlar bilan statistik jihatdan mos keldi (r² = 0.9984; p > 0.05). Raul usulida ΔTf oʻlchovi asosida hisoblangan izotonik konsentratsiyalar RSD < 1.5% aniqlik bilan aniqlandi. NaCl ekvivalenti usuli amaliy farmatsiyada eng keng tarqalgan va qoʻllanishi oson metodika ekanligi isbotlandi. Uchala usul oʻrtasidagi oʻrtacha farq 2.3 ± 0.7% ni tashkil etdi, bu ESV (eritmalar sifati validatsiyasi) mezonlarini qondiradi.References
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