Bioanalytical method for the estimation of co‐administered esomeprazole, leflunomide and ibuprofen in human plasma and in pharmaceutical dosage forms using micellar liquid chromatography

Abstract

The present study represents a connection between basic science and clinical applied science through providing a bioanalytical method for the analysis of certain co-administered drugs used for the treatment of rheumatoid arthritis. The studied drugs are esomeprazole, leflunomide and ibuprofen. The proposed bioanalytical method is a simple reversed phase high performance liquid chromatographic method using micellar mobile phase. The method is conducted using a Shim-pack VP-ODS (150 mm × 4.6 mm ID) stainless steel column at ambient temperature with ultraviolet detection at 285 nm. The micellar mobile phase consisted of 0.1 m sodium dodecyl sulfate, 10% n-propanol, 0.3% triethylamine in 0.02 m orthophosphoric acid (pH 3.5) and is pumped at a flow rate of 1.0 mL/min. The calibration curve was rectilinear over the concentration range of 0.1-5.0, 0.5-10.0 and 1.0-20.0 μg/mL for esomeprazole, leflunomide and ibuprofen respectively. The proposed method was successfully applied to the analysis of these drugs in dosage forms. The method is extended to the in-vitro, in-vivo determination of these drugs in spiked and real human plasma samples.

Nghiên cứu xây dựng phương pháp định lượng esomeprazol trong huyết tương thỏ bằng sắc ký lỏng khối phổ hai lần (LC-MS/MS)

“…Trên thế giới đã có nhiều nghiên cứu để xác định nồng độ esomeprazol trong dịch sinh học bằng HPLC-UV hoặc LC-MS/MS. Với HPLC-UV, Talaat và cộng sự (2017) đã xây dựng phương pháp định lượng nồng độ esomeprazol trong huyết tương và đạt được giới hạn định lượng dưới (LLOQ) rất thấp 0,092 ng/mL [4]. Tuy nhiên, phương pháp HPLC-UV thường có độ đặc hiệu thấp và phần lớn các nghiên cứu sử dụng LC-MS/MS để định lượng esomeprazol trong nền mẫu dịch sinh học.…”

Greening Reversed-Phase Liquid Chromatography Methods Using Alternative Solvents for Pharmaceutical Analysis

“…Table 2 lists the different, recent applications of MLC for analysis of drugs in both pharmaceutical and biological matrices [ 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 , 112 , 113 , 114 , 115 , 116 , 117 , 118 ]. Although most of these methods used SDS as a surfactant, some of them also used Brij-35 [ 92 , 93 ], cetyltrimethylammonium bromide (CTAB) [ 94 ], or Tween-20 [ 95 ].…”

Rapid Stability Indicating HPLC Method for the Analysis of Leflunomide and Its Related Impurities in Bulk Drug and Formulations

“…18 Bioanalytical methods are reported for estimation of LFNM in biological samples using HPLC, 19 HPTLC, 20 and liquid chromatography. 21 The other methods reported were determination of the active metabolite of LFNM in biological samples using HPLC. [22][23][24] No methods are reported for the estimation of LFLM and its USP related impurities in pharmaceutical formulations.…”