Thota, Bhavani
METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDIE S FOR DETERMINATION OF LURASIDONE HYDROCHLORIDE IN TABLET DOSAGE FORM BY R P-HPLC - Vol.10(12) - M P ABI Prints & Publishing Co. 2018 - 58-63p.
Objective:
To develop a simple, rapid, sensitive, precise, acc
urate, economical and validated reverse phase high
performance liquid
chromatographic (RP-HPLC) method for the estimation
of lurasidone hydrochloride in tablet dosage form.
Methods:
The chromatographic separation was carried out on a
prontosil C18, AQ (100 mm×4.6 mm, 3 μm) column. A
mixture of phosphate buffer
(pH 3.0): acetonitrile (ACN) (55:45v/v) was used as
a mobile phase. Flow rate of 1.0 ml/min and 10 μl i
njection volume was used for the assay. PDA
detector was used, and the detection wavelength was
230 nm. The retention time (RT) of lurasidone hydr
ochloride was found to be 4.505±0.01 min.
The method was validated according to the ICH guide
lines.
Results
:
The calibration curve for lurasidone hydrochloride
was linear with a correlation coefficient value 0.9
99 in the concentration range of 25-
125%. Specificity, accuracy (% mean recovery, 99.08
%), precision, detection limits, robustness (% RSD˂
2) and system suitability were found to be
within limits. Degradation studies were performed u
nder different stressed conditions, and the results
of degradation studies reveal that the
developed method was stable.
Conclusion:
The developed method was simple, reliable, economic
al and stable and it can be applied for the routine
quality control analysis of
lurasidone hydrochloride in tablet dosage forms.
PHARMACEUTICS
METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDIE S FOR DETERMINATION OF LURASIDONE HYDROCHLORIDE IN TABLET DOSAGE FORM BY R P-HPLC - Vol.10(12) - M P ABI Prints & Publishing Co. 2018 - 58-63p.
Objective:
To develop a simple, rapid, sensitive, precise, acc
urate, economical and validated reverse phase high
performance liquid
chromatographic (RP-HPLC) method for the estimation
of lurasidone hydrochloride in tablet dosage form.
Methods:
The chromatographic separation was carried out on a
prontosil C18, AQ (100 mm×4.6 mm, 3 μm) column. A
mixture of phosphate buffer
(pH 3.0): acetonitrile (ACN) (55:45v/v) was used as
a mobile phase. Flow rate of 1.0 ml/min and 10 μl i
njection volume was used for the assay. PDA
detector was used, and the detection wavelength was
230 nm. The retention time (RT) of lurasidone hydr
ochloride was found to be 4.505±0.01 min.
The method was validated according to the ICH guide
lines.
Results
:
The calibration curve for lurasidone hydrochloride
was linear with a correlation coefficient value 0.9
99 in the concentration range of 25-
125%. Specificity, accuracy (% mean recovery, 99.08
%), precision, detection limits, robustness (% RSD˂
2) and system suitability were found to be
within limits. Degradation studies were performed u
nder different stressed conditions, and the results
of degradation studies reveal that the
developed method was stable.
Conclusion:
The developed method was simple, reliable, economic
al and stable and it can be applied for the routine
quality control analysis of
lurasidone hydrochloride in tablet dosage forms.
PHARMACEUTICS