Stress Degradation Behaviour and Development Of Stability Indicating Rp Hplc Method For Simultaneous Estimation Of Combination Drug In Pharmaceutical Formulation
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Abstract
This paper presents an extensive review on the methods and techniques employed in
newlinepharmaceutical analysis, particularly focusing on the development and validation of
newlineanalytical methods in the context of combination drug formulations. The introduction
newlinediscusses the plethora of drugs available in various dosage forms and the instrumental
newlinetechniques commonly used for their estimation, such as spectrophotometry,
newlinechromatography, and high-performance liquid chromatography (HPLC). Method
newlinedevelopment in analytical chemistry, encompassing both quantitative and qualitative
newlineaspects, is highlighted as a challenging yet crucial process requiring thorough
newlineliterature review and experimental finesse. The choice of analytical method is
newlineinfluenced by factors like the nature of the material, desired accuracy, available
newlinefacilities, and time constraints.
newlineSubsequent sections delve into various analytical methods, including classical and
newlineinstrumental techniques, with a focus on spectrophotometric methods and HPLC.
newlineSpectrophotometric methods are praised for their simplicity, accuracy, and rapidity,
newlinemaking them invaluable in pharmaceutical analysis. The paper also discusses the
newlineprinciples and applications of HPLC, emphasizing its superiority in terms of speed,
newlineresolution, reproducibility, and automation. The choice of HPLC column and mobile
newlinephase is crucial and depends on the physical characteristics of the sample.
newlineThe importance of method validation in ensuring the reliability and accuracy of
newlineanalytical procedures is underscored, with a detailed discussion on parameters such as
newlineprecision, accuracy, limit of detection, and specificity. Stability-indicating methods in
newlineHPLC are highlighted as essential for differentiating between active pharmaceutical
newlineingredients and degradation products during stability testing. Forced degradation
newlinestudies under various conditions are recommended to evaluate the stability and
newlinerobustness of analytical methods.
newlineIn conclusion, the paper provides a comprehensive overview of analytical met