Journal of Pharmaceutical Research

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Method Development and Validation for Quantitative Analysis of Aspirin and Simvastatin in Pharmaceuticals by RP- HPLC


Affiliations
1 Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chandramoulipuram, Chowdavaram, Guntur-522 019 (A.P.), India
2 Chebrolu Hanumaiah institute of Pharmaceutical sciences, Chandramoulipuram, Chowdavaram, Guntur-522 019 (A.P.), India
3 Alkem Research Center, Industrial Estate, Opposite Talons Police Station, Navi Mumbai - 410 208, Maharashtra, India
4 Vignan Institute of Pharmaceutical Technology, Duvvada, Visakhapatnam - 530 046, (A.P.), India
 

A simple, accurate and precise reverse phase high performance liquid chromatography (RPHPLC) method has been developed and validated for the simultaneous determination of aspirin and simvastatin in combined dosage form. Separation was performed on a C18 column [ODS column, 250mm × 4.5mm with particle size 5μm. with a mobile phase consisting of acetonitrile: methanol: phosphate buffer (55:30:15) at a flow rate of 1ml/min and UV detection was carried out at 225nm. The developed method was validated for the parameters like system suitability, specificity, linearity, accuracy and robustness according to the ICH guidelines Q2B. Retention times of aspirin and simvastatin were found to be 3.4 and 7.44 respectively. Linearity was found in the range from 10-50μg/mL for aspirin and 2-10μg/mL for simvastatin with correlation coefficients 0.9998 and 0.9999 respectively. The % recovery for 100% spiked level was 99.44 and 101.20 for aspirin and simvastatin respectively. The developed method was accurate, robust, selective, linear and repeatable which could be used for routine analysis of aspirin and simvastatin in their combined dosage forms.

Keywords

Aspirin, Simvastatin, Simultaneous, RP-HPLC.
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  • Method Development and Validation for Quantitative Analysis of Aspirin and Simvastatin in Pharmaceuticals by RP- HPLC

Abstract Views: 201  |  PDF Views: 77

Authors

R. L. C. Sasidhar
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chandramoulipuram, Chowdavaram, Guntur-522 019 (A.P.), India
S. Vidyadhara
Chebrolu Hanumaiah institute of Pharmaceutical sciences, Chandramoulipuram, Chowdavaram, Guntur-522 019 (A.P.), India
N. T. Ramarao
Alkem Research Center, Industrial Estate, Opposite Talons Police Station, Navi Mumbai - 410 208, Maharashtra, India
Y. Srinivasa Rao
Vignan Institute of Pharmaceutical Technology, Duvvada, Visakhapatnam - 530 046, (A.P.), India
K. Tejaswi
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chandramoulipuram, Chowdavaram, Guntur-522 019 (A.P.), India

Abstract


A simple, accurate and precise reverse phase high performance liquid chromatography (RPHPLC) method has been developed and validated for the simultaneous determination of aspirin and simvastatin in combined dosage form. Separation was performed on a C18 column [ODS column, 250mm × 4.5mm with particle size 5μm. with a mobile phase consisting of acetonitrile: methanol: phosphate buffer (55:30:15) at a flow rate of 1ml/min and UV detection was carried out at 225nm. The developed method was validated for the parameters like system suitability, specificity, linearity, accuracy and robustness according to the ICH guidelines Q2B. Retention times of aspirin and simvastatin were found to be 3.4 and 7.44 respectively. Linearity was found in the range from 10-50μg/mL for aspirin and 2-10μg/mL for simvastatin with correlation coefficients 0.9998 and 0.9999 respectively. The % recovery for 100% spiked level was 99.44 and 101.20 for aspirin and simvastatin respectively. The developed method was accurate, robust, selective, linear and repeatable which could be used for routine analysis of aspirin and simvastatin in their combined dosage forms.

Keywords


Aspirin, Simvastatin, Simultaneous, RP-HPLC.