Determination of Residues of Acetaminophen, Caffeine, and Drotaverine Hydrochloride on Swabs Collected from Pharmaceutical Manufacturing Equipment Using HPLC in Support of Cleaning Validation

Q4 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Zayed, Ashraf G ; Hassouna, Mohamed E M ; Issa, Yousry M

AbstractAn HPLC method was developed for the simultaneous determination of residues of acetaminophen (paracetamol, PA), caffeine (CA), and drotaverine HCl (DH) on swabs collected from pharmaceutical manufacturing equipment surfaces. The challenge in cleaning validation is to develop analytical methods that are sensitive enough to detect traces of the active compounds remaining on the surface of pharmaceutical manufacturing equipment after cleaning. Chromatography was performed in the isocratic mode on a Hypersil C18 BDS column using the mobile phase 0.02 M tetrabutylammonium bisulfate–methanol (100 + 45, v/v) at 50°C with UV detection at 210 nm. The method was tested for specificity, linearity, LOD, LOQ, accuracy, and precision for determination of traces of the above-mentioned drugs. The time required for a single analysis was 12 min. The response was linear in the ranges of 6.900–52.100, 1.040–7.800, and 0.694–5.210 μg/mL for PA, CA, and DH, respectively.

01 Sep 2012·Journal of Liquid Chromatography & Related Technologies

SIMULTANEOUS DETERMINATION OF PARACETAMOL, CAFFEINE, DOMPERIDONE, ERGOTAMINE TARTRATE, PROPYPHENAZONE, AND DROTAVERINE HCL BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Author: Hassouna, Mohamed E. M. ; Issa, Yousry M. ; Zayed, Ashraf G.

A high performance liquid chromatog. (HPLC) method was developed for the simultaneous determination of paracetamol, (acetaminophen), caffeine, domperidone, ergotamine tartrate, propyphenazone, and drotaverine HCl.The chromatog. was performed in the isocratic mode on a Hypersil C18 BDS column using a mobile phase consisting of 0.02 mol L^-1 tetrabutylammonium bisulfate and methanol (100:45, volume/volume) at 50°C using UV detection at 210 nm.The method was validated by specificity, linearity, limit of detection, and limit of quantification, accuracy, and precision for the aforementioned drugs.The time required for a single anal. amounts to 14 min.The response was linear for the drug concentration ranges of 6.20-420.00, 0.80-80.00, 0.80-64.00, 2-40.00, 1.20-240.00, and 3.20-64.00, μg mL^-1 for PA, CA, DO, ET, PP, and DH, resp.Accuracy values for the method ranged from 99.40-101.94, 98.48-101.13, 98.97-100.54, 96.47-102.43, 98.92-101.82, and 97.63-100.45% for PA, CA, DO, ET, PP, and DH, resp.

Asian Journal of Pharmaceutical and Clinical Research

MODULATORY EFFECT OF POLYMER TYPE AND CONCENTRATION ON DRUG RELEASE FROM SUSTAINED RELEASE MATRIX TABLETS OF RANOLAZINE: A COMPARATIVE RELEASE KINETIC STUDY

Author: Abdel Hakeem, Wageeh ; Agiba, Ahmed M. ; Zayed, Ashraf G.

Objective: Ranolazine (RZ), antianginal drug indicated for the treatment of chronic stable angina pectoris, was formulated into sustained-release matrix tablets and optimized to improve patient compliance and achieve controlled release over a certain period. Methods: Different formulations were prepared by wet- and melt-granulation techniques. Excipients at different ratios as Eudragit® L100-55, Methocel™ E5, Avicel® PH-101, and carnauba wax powder were used to develop a ternary polymeric matrix system for the controlled delivery of RZ. The prepared formulations were subjected to granulometric and characteristic studies. Comparative dissolution and release kinetic studies of the selected formulation and the reference product, Ranexa® extended-release film-coated tablets, Gilead Sciences, Inc., USA, were further carried out to ensure product similarity. Results: The optimum pH-dependent to pH-independent polymers ratio was 1:1.3 (w/w). Extragranular carnauba wax in a concentration of 32.50 mg/tablet (2.50 gm% w/w) was the key excipient in controlling drug release kinetics by forming waxy matrix granules which prevent rapid dissolution. Modulation of the microenvironmental pH using a potent alkalinizing agent was very effective for controlling drug release patterns in different dissolution media from pH 1.2–6.8. Conclusion: The release of RZ from the matrix tablets was controlled for a period of 24 h, and thereby expected to provide patient compliance with minimal side effects.

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