Development and Validation of an HPLC Method for the Determination of Meloxicam and Pantoprazole in a Combined Formulation

Analytica

Raneem Ahmad¹  Zainab Zakaraya²  Mohammad Hailat³  Wael Abu Dayyih⁴  Osaid Al Meanazel⁵ 

[1]Faculty of Pharmacy and Medical Sciences, University of Petra, Amman 11196, Jordan

[2]Faculty of Pharmacy, Al-Ahliyya Amman University, Amman 19328, Jordan

[3]Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman 11733, Jordan

[4]Faculty of Pharmacy, Mutah University, Al-Karak 61710, Jordan

[5]Michael Sayegh Faculty of Pharmacy, Aqaba University of Technology, Aqaba 77110, Jordan

关键词: validation;    HPLC;    combination;    pantoprazole;    meloxicam;    formulation;   

DOI  :  10.3390/analytica3020012

来源: DOAJ

【 摘 要 】

Nonsteroidal anti-inflammatory drugs are the most commonly prescribed anti-inflammatory drugs worldwide. The most common side effects are gastrointestinal. Pantoprazole, a proton pump inhibitor (PPI), can be used to prevent these events from occurring. In this study, we attempt to develop and validate a novel method for determining and validating the fixed-dose combination of meloxicam and pantoprazole. A new method has been developed and validated to estimate pantoprazole and meloxicam in a fixed-dose combination using RP-HPLC. In order to separate the drugs, a mobile phase phosphate buffer/acetate was used (30:70, v/v), with a pH of 3.4 and a flow rate of 1.0 mL/min at 25 °C. The detection wavelength for the drugs was at a wavelength of 310 nm. The retention times for meloxicam and pantoprazole were 6 and 9 min, respectively. In concentrations ranging from 0.1 to 200 mg/L, the linearity of the detector was established. The r was 0.9998 for both drugs. Recovery rates ranged from 98 to 102% on average. According to the guidelines of the International Council on Harmonization, the results were satisfactory. Using the method presented herein, the pharmaceutical formulation of the combined meloxicam and pantoprazole can be routinely tested.

【 授权许可】

Unknown