Alam Prawez, Shakeel Faiyaz, Alshehri Sultan, Iqbal Muzaffar, Foudah Ahmed I, Alqarni Mohammed H, Aljarba Tariq M, Alhaiti Ali, Abdel Bar Fatma
Department of Pharmacognosy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, P.O. Box 173, Al-Kharj 11942, Saudi Arabia.
Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.
ACS Omega. 2024 May 15;9(21):23001-23012. doi: 10.1021/acsomega.4c02399. eCollection 2024 May 28.
The literature does not provide any "high-performance thin-layer chromatographic (HPTLC)" techniques for the determination of a novel antidiabetic medicine, ertugliflozin (ERZ). Additionally, there are not many environmentally friendly analytical methods for ERZ measurement in the literature. A rapid, sensitive, and eco-friendly reversed-phase-HPTLC (RP-HPTLC) method was designed and validated in an attempt to analyze ERZ in marketed pharmaceutical tablets more precisely, accurately, and sustainably over the traditional normal-phase HPTLC (NP-HPTLC) method. The stationary phases used in the NP- and RP-HPTLC procedures were silica gel 60 NP-18F254S and 60 RP-18F254S plates, respectively. For NP-HPTLC, a chloroform/methanol (85:15 v/v) mobile phase was used. However, ethanol-water (80:20 v/v) was the preferred method for RP-HPTLC. Four distinct methodologies, including the National Environmental Method Index (NEMI), Analytical Eco-Scale (AES), ChlorTox, and Analytical GREEnness (AGREE) approaches, were used to evaluate the greenness of both procedures. For both approaches, ERZ detection was carried out at 199 nm. Using the NP- and RP-HPTLC techniques, the ERZ measurement was linear in the 50-600 and 25-1200 ng/band ranges. The RP-HPTLC method was found to be more robust, accurate, precise, linear, sensitive, and eco-friendly compared to the NP-HPTLC approach. The results of four greenness tools demonstrated that the RP strategy was greener than the NP strategy and all other reported HPLC techniques. The fact that both techniques can assess ERZ when its degradation products are present implies that they both have characteristics that point to stability-indicating features. 87.41 and 99.28%, respectively, were the assay results for ERZ in commercial tablets when utilizing the NP and RP procedures. Based on several validation and greenness metrics, it was determined that the RP-HPTLC approach was better than the NP-HPTLC method. As a result, it is possible to determine ERZ in pharmaceutical products using the RP-HPTLC approach.
文献中未提供用于测定新型抗糖尿病药物依鲁格列净（ERZ）的“高效薄层色谱（HPTLC）”技术。此外，文献中也没有很多用于测定ERZ的环境友好型分析方法。设计并验证了一种快速、灵敏且环保的反相HPTLC（RP-HPTLC）方法，旨在比传统的正相HPTLC（NP-HPTLC）方法更精确、准确且可持续地分析市售药片中的ERZ。NP-HPTLC和RP-HPTLC程序中使用的固定相分别为硅胶60 NP-18F254S板和60 RP-18F254S板。对于NP-HPTLC，使用氯仿/甲醇（85:15 v/v）流动相。然而，乙醇-水（80:20 v/v）是RP-HPTLC的首选方法。使用包括国家环境方法指数（NEMI）、分析生态尺度（AES）、ChlorTox和分析绿色度（AGREE）方法在内的四种不同方法来评估这两种程序的绿色度。对于这两种方法，ERZ检测均在199 nm处进行。使用NP-HPTLC和RP-HPTLC技术，ERZ测量在50 - 600 ng/带和25 - 1200 ng/带范围内呈线性。与NP-HPTLC方法相比，发现RP-HPTLC方法更稳健、准确、精密、线性、灵敏且环保。四种绿色度工具的结果表明，RP策略比NP策略以及所有其他已报道的HPLC技术更环保。当存在ERZ的降解产物时，两种技术都能对其进行评估，这一事实表明它们都具有指向稳定性指示特征的特性。使用NP和RP程序时，市售药片中ERZ的含量测定结果分别为87.41%和99.28%。基于多项验证和绿色度指标，确定RP-HPTLC方法优于NP-HPTLC方法。因此，使用RP-HPTLC方法可以测定药品中的ERZ。
