DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR QUANTIFICATION OF ACETIC ACID CONTENT IN AMLODIPINE BESYLATE
By: Haqur, SK Manirul
.
Contributor(s): Saisree, K.
Publisher: M P Innovare Academic Sciences Pvt Ltd 2019Edition: Vol.11(4).Description: 8-11p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
International journal of pharmacy and pharmaceutical scienceSummary: Objective:
To develop and validate
a simple and accurate cost-effective titrimetric me
thod according to International Conference Harmoniz
ation
(ICH) guidelines for acetic acid content in Amlodipi
ne Besylate.
Methods:
The titration based on general acid-base reaction t
o form water and salt. Sodium hydroxide act as a st
rong base and titrated against weak
acid (acetic acid). Phenolphthalein used as an indi
cator and colorless to pink is the endpoint. Sodium
hydroxide is standardized with primary
standard potassium hydrogen phthalate.
Results:
The method was linear in the range of 0.75 to 30.25
μg/ml with a correlation coefficient 0.9999. Limit
of detection (LOD) and limit of
quantitation (LOQ) value were found to be 0.61 and
1.85 μg/ml, respectively. The percentage recovery (
98.20–99.97%) and percentage relative
standard deviation (%RSD) is less than 2% within th
e acceptable limit of ICH guidelines. The robustness
and ruggedness results were excellent.
Method is accurate and precise, no interference fro
m excipients.
Conclusion:
A new analytical titrimetric method was developed a
nd validated as per ICH guidelines for the determin
ation of acetic acid content in
amlodipine. This proposed method applied for routin
e analysis of acetic acid content in bulk and pharm
aceutical formulations of amlodipine besylate.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
|
School of Pharmacy Archieval Section | Not for loan | 2020900 |
Objective:
To develop and validate
a simple and accurate cost-effective titrimetric me
thod according to International Conference Harmoniz
ation
(ICH) guidelines for acetic acid content in Amlodipi
ne Besylate.
Methods:
The titration based on general acid-base reaction t
o form water and salt. Sodium hydroxide act as a st
rong base and titrated against weak
acid (acetic acid). Phenolphthalein used as an indi
cator and colorless to pink is the endpoint. Sodium
hydroxide is standardized with primary
standard potassium hydrogen phthalate.
Results:
The method was linear in the range of 0.75 to 30.25
μg/ml with a correlation coefficient 0.9999. Limit
of detection (LOD) and limit of
quantitation (LOQ) value were found to be 0.61 and
1.85 μg/ml, respectively. The percentage recovery (
98.20–99.97%) and percentage relative
standard deviation (%RSD) is less than 2% within th
e acceptable limit of ICH guidelines. The robustness
and ruggedness results were excellent.
Method is accurate and precise, no interference fro
m excipients.
Conclusion:
A new analytical titrimetric method was developed a
nd validated as per ICH guidelines for the determin
ation of acetic acid content in
amlodipine. This proposed method applied for routin
e analysis of acetic acid content in bulk and pharm
aceutical formulations of amlodipine besylate.
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