Asian Journal of Pharmaceutical Analysis

Hamid Khan ¹, Mushir Ali ¹, Alka Ahuja ¹, Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG-495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi-110062, IN

Abstract

In the presented work identification and quantification of some anti-inflammatory and analgesic drugs, namely aceclofenac, diclofenac, paracetamol and para-aminophenol were carried out by validated HPLC-UV method. The chromatographic separation was achieved on HPLC C₁₈ (100.0 × 2.1 mm, 1.7μm) column using isocratic mobile phase consisting of acetonitrile-phosphate buffer (50:50, v/v) at a flow rate of 1.0 mL/min. The UV detection was carried out at 275 nm for all the compounds. The elution of aceclofenac, diclofenac, paracetamol and para-aminophenol was occurred at 7.0, 9.2, 2.0 and 4.2 min, respectively. The calibration curves were linear over the concentration range of 1-1000 μg/mL for aceclofenac and paracetamol, and 1-100 μg/mL for diclofenac and para-aminophenol. The developed method was validated according to ICH guidelines. The method was applied in the identification and quantitative determination of these compounds during routine quality control analysis and in stability studies.

Keywords

HPLC-UV, Aceclofenac, Paracetamol, Diclofenac, Para-Aminophenol, Validation.

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Hamid Khan ¹, Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, -110062, IN

Abstract

Impurity profiling and identification of degradation product is an essential part of pharmaceutical development program. Impurity profiling is mandatory requirement by various regulatory agencies and is directly related with the quality, safety and efficacy of a drug product. The ultimate purpose of impurity profiling and stress testing is in the establishment of the degradation products pathways and to investigate the stability-indicating power of the analytical procedures which is ultimately helpful in the prediction of shelf life of drug product. Hyphenated technique is combination a combination of two different analytical techniques with the help of proper interface. Mainly chromatographic techniques are combined with the spectroscopic techniques. This write up provides a review on brief information about role of different hyphenated analytical techniques such as HPLC-UV, HPLCMS, GC-MS and UPLC-MS/MS for identification of impurities and degradation products in pharmaceutical products.

Keywords

Identification, Impurities, Degradation Products, Stress Testing, Analytical Techniques.

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Hamid Khan ¹, Mushir Ali ², Alka Ahuja ², Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi-110062, IN

Abstract

In the presented work the ultra-performance liquid chromatographic/quadrupole time-of-flight mass spectrometric (UPLC/Q-TOF-MS) method has been developed for pharmacokinetic study of some antiinflammatory and analgesic drugs in human plasma. The aceclofenac, paracetamol, and chlorzoxazone were analyzed by Acquity UPLC BEH C18 (100.0_2.1 mm, 1.7 lm) column using isocratic mobile phase consisting of acetonitrile-2mM ammonium acetate (50:50, v/v) at a flow rate of 0.20 mL/min. The Q-TOF mass spectrometer was operated in positive ionization mode and quantization was done using the MS/MS transitions m/z 354.07 to 215.07 for aceclofenac, 152.07 to 110.06 for paracetamol and 170.00 to 134.00 for chlorzoxazone. The calibration curves were linear over the concentration range of 1-1000 ng/mL for all the drugs. The developed method was validated according to ICH guidelines. The method was applied for pharmacokinetic study of tablets containing aceclofenac, paracetamol, and chlorzoxazone in human plasma.

Keywords

UPLC/Q-TOF-MS, Aceclofenac, Paracetamol, Chlorzoxazone, Pharmacokinetic Study.

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Hamid Khan ¹, Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 110062, IN

Abstract

High Performance Liquid Chromatography (HPLC) is a major analytical technique for qualitative and quantitative drug analysis. More than 90% of drugs prescribed in official pharmacopoeias are being analyzed HPLC. But due to the higher regulatory requirements such as more number of samples, speed of analysis, and sensitivity of the method of analysis. The pharmaceutical industries adopting the more advanced chromatographic techniques. Ultra-high Performance Liquid Chromatography (UHPLC) offers an advancement of HPLC which is based on the principal of use of stationary phase consisting of particles less than 2μm. By using smaller particles, speed of analysis, peak capacity can be extended to new limits and the sample can be analyzed in a shorter period of time. The UHPLC technique is a new approach in the chromatographic separations and has been successfully employed for fast, high resolution separations with required sensitivity. This review provides the brief introduction and applications of UHPLC in the pharmaceutical analysis.

Keywords

UHPLC, UPLC, Introduction, Applications, Pharmaceutical Analysis.

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