Current Issue : January-March Volume : 2021 Issue Number : 1 Articles : 2 Articles
Forced degradation is the study of the chemical stability of a new drug product and drug substance at the condition of more severe than accelerated condition. The forced degradation study illustrates the chemical stability of the drug molecules which further facilitates the development of stable formulation with suitable storage conditions. Regulatory guideline USFDA, ICH, EMA, ANVISA demonstrate certain degradation conditions like light, oxidation, heat, acidic, basic, hydrolysis effect on drug product and drug substance due to these condition stability of the drug product and drug substance affect and reduce their stability so the guideline suggests to performed stability study on new drug product and drug substance. ICH Q1A, Q1B, Q1C, Q1D, Q1E and Q1F are the example of the stability testing study which is also called as forced degradation study of the product molecules. Stability indicating a method to develop forced degradation of the drug product and drug substance. This review gives information about current strategic approaches and trends in forced degradation studies....
Chromatography is the science which deals with the separation of molecules based on differences in their structure and composition. In present study the analytical methods were developed and validated for anti bacterial drug in bulk and multiple component formulation. In the first part HPLC method was developed and validated for both moxifloxacin and cefixime in bulk and tablet formulation (Alexime-M). Method was found to be accurate, precise, rapid and selective; moreover the developed method required the shorter duration of analysis for moxifloxacin and cefixime and hence can be conveniently used for routine quality control analysis for both the drugs in combination, the Rt of MOXI was 4.0 and CEF was 2.47 mins respectively, developed method was found to be specific as there was no interference of the excipients, which was confirmed by the absence of extra peaks. In second part the HPTLC method was developed and validated of moxifloxacin and cefixime in bulk and dosage form. HPTLC in pharmaceutical analysis represents a major step in terms of quality-control analysis and quantitative determination in formulations. The developed HPTLC technique was found to be precise, accurate and specific. Statistical analysis proves that the method was suitable for the simultaneous determination of moxifloxacin and cefexime in bulk and combined dosage form....
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