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ANANBIOANAL - 2010
Pharmaceutical R & D Summit
doi:10.4172/2155-9872.1000075
A Validated Stability Indicating RP-HPLC Method for the
Determination of Amlodipine Besylate and Telmisartan in
Pharmaceutical Formulation
Asha B. Thomas
Dr.D.Y.Patil Institute Of Pharmaceutical Sciences and Research, Pune, India
A
new Reversed Phase-High Performance Liquid Chomatographic method
was developed and validated for the quantitation of Amlodipine besylate and
Telmisartan in pharmaceutical formulations. Determination was performed on a
HPLC Binary gradient system (Agilent Technologies, 1120 Compact LC HPLC)
using a Hypersil-BDS (C-18
containing 0.05 M potassium dihydrogen ortho phosphate: acetonitrile (60:40%
v/v) in isocratic mode at a flow rate of 1.4 mL/min with UV detection at 237.0 nm.
The retention time (tR
8.53 min respectively. The response was linear in the concentration range of 1-50
µg mL-1
for both Amlo and Tel with regression coefficient (r2
, 0.10664 µgmL-1
and 0.04663 µg mL-1
, 0.14132 µg mL-1
respectively. The method was validated for precision, accuracy robustness and
ruggedness as per ICH guidelines. The LOD and LOQ were found to be 0.03512 µg
mL-1
for Amlodipine besylate
and Telmisartan respectively. The mean recoveries of Amlodipine besylate and
Telmisartan were found to be 99.78% and 100.02% respectively. The robustness of
the developed RP-HPLC method evaluated by making deliberate variations in the
method parameters such as change in flow rate [-0.1 level- 1.3 ml/min; 0.0 level- 1.4
ml/min; +0.1 level -1.50ml/min], ratio of aqueous: organic composition and pH of the
mobile phase [+1:-1 level-(61:39/pH-6.41); 0:0 level -(60:40/pH-6.50);-1:+1 level -
(59:41/ pH-6.47)] on the retention time, tailing factor and % content indicated that
the developed method was unaffected by small changes in method parameters and
is robust. The ruggedness of the developed method which was also evaluated by
studying the effect of parameters like different analysts and chemicals and solvents
(Qualigens- Thermo Fisher Scientific India Pvt. Ltd., Mumbai, India and Universal
Labs. Mumbai, India) employed exhibited low % R.S.D values for retention time,
tailing factor and % content indicating that the developed method is rugged. The
specificity of the method evaluated by forced degradation studies suggest that the
method could effectively separate the drugs from its degradation products and
can be used for stability-indicating analysis. Due to its simplicity, high precision
and accuracy, the proposed RP-HPLC method can be used for the estimation of
Amlodipine besylate and Telmisartan in pharmaceutical preparations.
) for Amlodipine besylate and Telmisartan were 5.47min and
) 0.9987 and 0.999
) column (5 μm, 250 mm 4.60 mm), a mobile phase
ANALBIOANAL-2010
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