Validated Stability Indicating Eco-friendly RP-HPLC Method for the Concurrent Quantification of Gabapentin and Diclofenac KAin Wastewater and Pharmaceutical Formulations

被引:0
作者
Mahgoub, Samar M. [1 ]
Elsherief, Asmaa H. [2 ]
Mahmoud, Rehab [3 ]
Mahmoud, M. Ramadan [4 ]
Mohamed, Mahmoud A. [5 ]
机构
[1] Beni Suef Univ, Fac Postgrad Studies Adv Sci, Mat Sci & Nanotechnol Dept, Bani Suwayf 62764, Egypt
[2] Ahram Canadian Univ, Fac Pharm, 6 October 12573, Egypt
[3] Beni Suef Univ, Fac Sci, Dept Chem, Bani Suwayf 62511, Egypt
[4] Al Azhar Univ, Fac Pharm, Assiut 71524, Egypt
[5] Hikma Pharmaceut Co, Bani Suwayf 62541, Egypt
来源
EGYPTIAN JOURNAL OF CHEMISTRY | 2024年 / 67卷 / 01期
关键词
Gabapentin; Diclofenac K; Eco-friendly HPLC; Wastewater; ICH guidelines; Validation; SPECTROPHOTOMETRIC METHOD; PAIN; SODIUM; DEGRADATION; PREGABALIN; UV;
D O I
10.21608/EJCHEM.2023.213243.8018
中图分类号
O6 [化学];
学科分类号
0703 ;
摘要
The concurrent detection of gabapentin (GAP) and diclofenac K (DIC) in pharmaceutical formulations and wastewater has been made more approachable by developing and validating a precise Eco-friendly HPLC method. We evaluated the environmental impact of the RP-HPLC method using AGREEprep. AThis ensured that the technique was effective and sustainable. Separation by HPLC was accomplished on a C18, 5 mu m Hypersil column (150 mm x 4.6 mm) with a mobile phase composed of monobasic phosphate buffer pH 6.2: Methanol in a ratio of 50:50 and pumped at 1.5 mL/min. UV was detected at a wavelength of 210 nm and 275 nm for GAP and DIC, respectively. Obtaining retention times (Rt) of 1.30 min and 9.58 min, respectively. Limits of quantitation and detection, as well as specificity, linearity, precision, accuracy, robustness, and stability, were all validated for this technique per ICH requirements. The method was specific, precise, accurate, and reproducible. The linearity study was established for GAP and DIC in the 3-50 mu g/mL range. It was discovered that the limits of both detection and quantification were 0.93 mu g/mL and 2.82 mu g/mL for GAP, whereas the results were 1.25 mu g/mL and 3.78 mu g/mL for GAP and DIC, respectively. Good accuracy, recovery, and precision of drugs from their commercial pharmaceutical formulations (99.01, 100.35%) and wastewater samples (100.84, 100.52%) for GAP and DIC, respectively. This approach has been effectively used for the quantitative measurement of GAP and DIC in commercial tablets and wastewater, and it is robust for minor or deliberate adjustments to the chromatographic variables.
引用
收藏
页码:411 / 422
页数:12
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