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JP harm Sci Bioscientific Res. 2018. 8 (2):123129ISSN NO. 22713681Stability Indicating HPLC Method for Simultaneous Estimation of and Hydrochloride Tablet Dosage Form Paschal Himanshu×1, Hakka Divya2
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01
Start by thoroughly understanding the method development and validation requirements for stability indicating HPLC method.
02
Gather all the necessary materials and equipment required for the method.
03
Begin by preparing the mobile phase and ensuring its stability.
04
Prepare the sample solution by accurately weighing or measuring the required amount of sample.
05
Inject the sample solution into the HPLC system and adjust the necessary parameters such as flow rate, column temperature, and detector wavelength.
06
Run the chromatographic analysis, ensuring that the peaks of interest are well-resolved and well-separated from any potential degradation products or impurities.
07
Validate the stability indicating capability of the method by subjecting the sample solution to various stress conditions such as high temperature, light exposure, and acidic/basic conditions.
08
Analyze the stressed samples and monitor the degradation of the compounds of interest.
09
Ensure that the method is able to accurately and precisely detect and quantify the compounds of interest even in the presence of degradation products or impurities.
10
Document all the necessary information and results obtained during the stability indicating HPLC method development and validation process.

Who needs stability indicating hplc method?

01
Stability indicating HPLC method is primarily needed by analytical laboratories and pharmaceutical companies involved in drug development and manufacturing.
02
It is also required by regulatory authorities such as FDA (Food and Drug Administration) to demonstrate the stability and quality of pharmaceutical products.
03
Researchers and scientists working on stability studies of drugs or chemicals also utilize stability indicating HPLC methods to assess the degradation patterns and establish shelf-life of the substances.
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The stability indicating hplc method is a analytical technique used to study the stability of drugs and pharmaceutical products over time.
Pharmaceutical companies and drug manufacturers are required to file stability indicating hplc method.
To fill out stability indicating hplc method, one must follow the guidelines provided by regulatory authorities and accurately report the analytical data.
The purpose of stability indicating hplc method is to determine the degradation products and stability of drugs under different conditions.
The stability indicating hplc method must report information such as sample preparation, method validation, chromatographic conditions, and results interpretation.
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