A Validated Capillary Electrophoretic Method for the Determination of Olopatadine and Its Application to a Pharmaceutical Preparation of Eye Drops

Abstract

A validated rapid and sensitive capillary zone electrophoretic method for the determination of olopatadine hydrochloride (OLO) is described. Optimum conditions were found: 20 mmol/L sodium tetraborate buffer, acetonitrile 15% (v/v), 10 mmol/L NaCl at pH 9.5, with 25 kV of applied potential, injection time of 10 s at 5 × 103 N/m2, at a wavelength of 205 nm, and fixed temperature of 30°C. The calibration curve was linear in the range of 1.13 × 10-5 mol/L (4.22 μg/mL) to 5.65 × 10-5 mol/L (21.12 μg/mL), with R = 0.9995 for interday precision. LOD and LOQ values were 1.58 × 10-6 (0.58 μg/mL) and 4.78 × 10-6 mol/L (1.75 μg/mL), respectively. Precision values were 1.10-1.97% for intraday and 1.41% for interday RSDs. Accuracy was tested by preparing a synthetic mixture whose composition was similar to the pharmaceutical preparation for Patanol. The RSDs of the recovery values (98.2%) were between 0.42 and 0.65% and the amount of OLO found was 1.09 mg/mL. The result was within the requirements of USP 31-NF 26. Therefore, this validated method is suggested for routine analysis for the determination of OLO in laboratories.

Review Article: Instrumental Analysis of Olopatadine Hydrochloride, Oxeladine Citrate, Amlodipine Besylate and Xipamide

“…In this method the standard and sample solutions of olopatadine hydrochloride were prepared in methanol. Olopatadine hydrochloride was estimated at 224 nm for the second order derivative UV -spectrophotomet-formed [15]. The validated capillary zone electrophoretic method for the determination of olopatadine hydrochloride is described at pH 9.5, with 25 kV.…”

Simultaneous determination of four phenolic acids in traditional Chinese medicine by capillary electrophoresis-chemiluminescence

“…It offers numerous advantages over conventional chromatographic methods because of its unique separation mechanism, speed, higher efficiency, versatility, environmental friendliness, resources utilization, small sample amount, not requiring further purification, and permitting several kinds of buffers and additives for usage as the electrolyte. 20,21 CE has many applications in biochemistry, pharmaceutical science, 22 bioscience, 23 ion analysis, 24 food analysis, 25 and environmental science fields. 24 …”

Intrinsic Stability Study and Forced Degradation Profiling of Olopatadine Hydrochloride by RP-HPLC-DAD-HRMS Method

“…[5][6][7][8][9] Analytical methods for OLO determination in different matrices have been reported, i.e. radioimmunoassay, 10 liquid chromatography (LC) with tandem mass spectrometry, 11 LC-ESI-MS-MS, 12,13 capillary zone electrophoretic method, 14 high performance LC (HPLC), and high-performance thin-layer chromatography (HPTLC), 15 but there is no study reported on forced degradation profiling including the intrinsic stability of OLO. The objective of forced degradation is to provide guidance for the development of executing purposeful degradation experiments for pharmaceutical drug candidates.…”