Haqur, SK Manirul <br/><br/>
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR  QUANTIFICATION OF  ACETIC ACID CONTENT IN AMLODIPINE BESYLATE  

 - Vol.11(4) 
 - M P  Innovare Academic Sciences Pvt Ltd  2019 
 - 8-11p 
<br/><br/> Objective: <br/>To develop and validate<br/>a simple and accurate cost-effective titrimetric me<br/>thod according to International Conference Harmoniz<br/>ation <br/>(ICH) guidelines for acetic acid content in Amlodipi<br/>ne Besylate.  <br/>Methods: <br/>The titration based on general acid-base reaction t<br/>o form water and salt. Sodium hydroxide act as a st<br/>rong base and titrated against weak <br/>acid (acetic acid). Phenolphthalein used as an indi<br/>cator and colorless to pink is the endpoint. Sodium<br/> hydroxide is standardized with primary <br/>standard potassium hydrogen phthalate. <br/>Results: <br/>The method was linear in the range of 0.75 to 30.25<br/> μg/ml with a correlation coefficient 0.9999. Limit<br/> of detection (LOD) and limit of <br/>quantitation (LOQ) value were found to be 0.61 and <br/>1.85 μg/ml, respectively. The percentage recovery (<br/>98.20–99.97%) and percentage relative <br/>standard deviation (%RSD) is less than 2% within th<br/>e acceptable limit of ICH guidelines. The robustness<br/> and ruggedness results were excellent. <br/>Method is accurate and precise, no interference fro<br/>m excipients. <br/>Conclusion: <br/>A new analytical titrimetric method was developed a<br/>nd validated as per ICH guidelines for the determin<br/>ation of acetic acid content in <br/>amlodipine. This proposed method applied for routin<br/>e analysis of acetic acid content in bulk and pharm<br/>aceutical formulations of amlodipine besylate.  
<br/><br/><label>Subjects--Topical Terms: </label><br/>PHARMACEUTICS