Alam Prawez, Ezzeldin Essam, Iqbal Muzaffar, Anwer Md Khalid, Mostafa Gamal A E, Alqarni Mohammed H, Foudah Ahmed I, Shakeel Faiyaz
Department of Pharmacognosy, College of Pharmacy, Prince Sattam Bin Abdulaziz University Al-Kharj Saudi Arabia.
Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University Riyadh Saudi Arabia.
RSC Adv. 2020 Jan 10;10(4):2133-2140. doi: 10.1039/c9ra07825h. eCollection 2020 Jan 8.
A literature survey revealed no suitable "reversed phase-high performance thin layer chromatography (RP-HPTLC)" method for the analysis of rivaroxaban in nanoparticle (NP) formulations. Therefore, a novel rapid, simple, economical and environment friendly RP-HPTLC method has been established for the quantification of rivaroxaban in NP formulations and commercial tablets. RP-HPTLC analysis of rivaroxaban was performed using "RP-18 silica gel 60 F254S HPTLC plates". The binary mixture of green solvents ethanol : water (7 : 3 v/v) was utilized as the mobile phase. The quantification of rivaroxaban was carried out in densitometric mode at = 253 nm. Rivaroxaban peaks from NP formulations was confirmed by comparing its single spot at = 0.71 ± 0.02 with that of the standard. The proposed RP-HPTLC method was found to be linear in the range of 50-600 ng per band with = 0.9994. The equation for linear regression analysis was obtained as = 13.28 + 1189.4. The proposed RP-HPTLC technique was validated for "precision, accuracy, robustness and sensitivity". The accuracy of the method was obtained as 97.97-99.67%. The % RSD in repeatability and intermediate precision was recorded as 0.46-0.64 and 0.48-0.86%, respectively. The LOD and LOQ for rivaroxaban were obtained as 18.45 and 55.35 ng per spot, respectively. The % content of rivaroxaban in marketed tablets and NPs was recorded as 99.20 and 98.08%, respectively. The proposed RP-HPTLC technique could be successfully applied for the pharmaceutical assay of rivaroxaban in NPs, marketed tablets and related formulations.
文献调研表明,没有合适的“反相高效薄层色谱法(RP-HPTLC)”用于分析纳米颗粒(NP)制剂中的利伐沙班。因此,已建立一种新型的快速、简便、经济且环境友好的RP-HPTLC方法,用于定量NP制剂和市售片剂中的利伐沙班。使用“RP-18硅胶60 F254S HPTLC板”对利伐沙班进行RP-HPTLC分析。以乙醇∶水(7∶3 v/v)的绿色二元混合溶剂作为流动相。在253 nm波长下以密度测定模式对利伐沙班进行定量。通过将NP制剂中的利伐沙班峰在Rf = 0.71±0.02处的单点与标准品的单点进行比较来确认。所提出的RP-HPTLC方法在每条带50 - 600 ng范围内呈线性,r = 0.9994。线性回归分析方程为y = 13.28x + 1189.4。所提出的RP-HPTLC技术针对“精密度、准确度、稳健性和灵敏度”进行了验证。该方法的准确度为97.97 - 99.67%。重复性和中间精密度的相对标准偏差(%RSD)分别记录为0.46 - 0.64%和0.48 - 0.86%。利伐沙班的检测限(LOD)和定量限(LOQ)分别为每点18.45 ng和55.35 ng。市售片剂和NP中利伐沙班的含量百分比分别记录为99.20%和98.08%。所提出的RP-HPTLC技术可成功应用于NP、市售片剂及相关制剂中利伐沙班的药物分析。