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High Performance Liquid Chromatographic Fluorescence Detection Method for the Quantification of Rivastigmine in Rat Plasma and Brain: Application to Preclinical Pharmacokinetic Studies in Rats
Pharmaceutical Analysis
High Performance Liquid Chromatographic Fluorescence 'HWHFWLRQ0HWKRGIRUWKH4XDQWL¿FDWLRQRI5LYDVWLJPLQHLQ5DW Plasma and Brain: Application to Preclinical Pharmacokinetic Studies in Rats Arumugam K, Chamallamudi MR, Mallayasamy SR, Mullangi R1, Ganesan S, Jamadar L, Ranjithkumar A2, Udupa N Department of Pharmaceutical Sciences, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, 1Jubilant Biosys, Industrial Suburb, Yeshwanthpur, Bangalore, India, 2Department of Pharmaceutical Sciences, College of Pharmacy, South Dakota State University, Brookings, South Dakota, USA Address for correspondence: Dr. Mallikarjuna Rao Chamallamudi; E-mail: [email protected]
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INTRODUCTION
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Journal of Young Pharmacists Vol 3 / No 4
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Figure 1: Structural representation of rivastigmine (RSM) and XGPNCHCZKPG +5 316
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Table 1: ,ntra- anG inter-Gay precision Gata of tKe 5S0 in rat plasma anG brain Quality control
Intra-day variation (six replicates at each concentration LLOQ
LQC
MQC
HQC
Inter-day variation (2 replicates at each concentration LLOQ LQC MQC HQC
Run
1 2 3 1 2 3 1 2 3 1 2 3
Measured concentration of RSM in plasma (ng/mL) Mean SD RSD (%) Accu (%)*
Measured concentration of RSM in brain homogenate (ng/mL) Mean SD RSD (%) Accu (%)*
21 93 1 91 3 32 2 299 19 111 11 119 2 1 2
13 1 1 1 3 32 2 1 1332 1129 121 292 931 112
1 12 19 121 12 112 123 132 93 1 93 119 911 1219 1212
21 93 1 91 11 1 99 99 999 1 991 113 93 9 9 1323
913 9 292 22 32 22 122 1933 12 121 912 929 921 21
13 13 1 12 2 32 31 3 3 1219 13 133 2 121
19 199 19 1 9 112 119 1239 93 1 11 99 1222 192 132 1
913 9 99 92 193 91 9 99 9 91 9 9 93
33 12 919
2 1 139 1
9 93 1
3 1123 119 91
91 292 1 31
22 123 322 9
2 23 221 39
9 93 92 9133
R6' Relative standard deviation (6' î 1mean *Accu (accuracy = (mean assayed concentration ± nominal concentration (nominal concentration î1
Journal of Young Pharmacists Vol 3 / No 4
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Stability
LQC
In inMector (12 h Bench top ( h Third Ireezethaw 3 day at -C In inMector (12 h Bench top ( h Third Freezethaw 3 day at -C
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Mean 2 3232 31 22 99 3 39 32
Measured concentration of RSM in plasma (ng/mL) SD Accu (%)* 33 923 32 13 2 9 3 9 13 113 32 9233 93 9 39 9
% CV 11 133 2 13 11 1 121 2
Measured concentration of RSM in brain homogenate (ng/mL) Mean SD Accu (%)* % CV 39 33 131 11 2 1 9293 19 3 292 12 99 22 33 92 123 22 9 9 122 3 22 99 1 929 3 9 111 912 91 13
CV (precision coeI¿cient oI variation *Accu (accuracy (mean assayed concentration ± nominal concentration (nominal concentration î1
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High Performance Liquid Chromatographic Fluorescence 'HWHFWLRQ0HWKRGIRUWKH4XDQWL¿FDWLRQRI5LYDVWLJPLQHLQ5DW Plasma and Brain: Application to Preclinical Pharmacokinetic Studies in Rats Arumugam K, Chamallamudi MR, Mallayasamy SR, Mullangi R1, Ganesan S, Jamadar L, Ranjithkumar A2, Udupa N Department of Pharmaceutical Sciences, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, 1Jubilant Biosys, Industrial Suburb, Yeshwanthpur, Bangalore, India, 2Department of Pharmaceutical Sciences, College of Pharmacy, South Dakota State University, Brookings, South Dakota, USA Address for correspondence: Dr. Mallikarjuna Rao Chamallamudi; E-mail: [email protected]
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Figure 1: Structural representation of rivastigmine (RSM) and XGPNCHCZKPG +5 316
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Table 1: ,ntra- anG inter-Gay precision Gata of tKe 5S0 in rat plasma anG brain Quality control
Intra-day variation (six replicates at each concentration LLOQ
LQC
MQC
HQC
Inter-day variation (2 replicates at each concentration LLOQ LQC MQC HQC
Run
1 2 3 1 2 3 1 2 3 1 2 3
Measured concentration of RSM in plasma (ng/mL) Mean SD RSD (%) Accu (%)*
Measured concentration of RSM in brain homogenate (ng/mL) Mean SD RSD (%) Accu (%)*
21 93 1 91 3 32 2 299 19 111 11 119 2 1 2
13 1 1 1 3 32 2 1 1332 1129 121 292 931 112
1 12 19 121 12 112 123 132 93 1 93 119 911 1219 1212
21 93 1 91 11 1 99 99 999 1 991 113 93 9 9 1323
913 9 292 22 32 22 122 1933 12 121 912 929 921 21
13 13 1 12 2 32 31 3 3 1219 13 133 2 121
19 199 19 1 9 112 119 1239 93 1 11 99 1222 192 132 1
913 9 99 92 193 91 9 99 9 91 9 9 93
33 12 919
2 1 139 1
9 93 1
3 1123 119 91
91 292 1 31
22 123 322 9
2 23 221 39
9 93 92 9133
R6' Relative standard deviation (6' î 1mean *Accu (accuracy = (mean assayed concentration ± nominal concentration (nominal concentration î1
Journal of Young Pharmacists Vol 3 / No 4
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Stability
LQC
In inMector (12 h Bench top ( h Third Ireezethaw 3 day at -C In inMector (12 h Bench top ( h Third Freezethaw 3 day at -C
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Mean 2 3232 31 22 99 3 39 32
Measured concentration of RSM in plasma (ng/mL) SD Accu (%)* 33 923 32 13 2 9 3 9 13 113 32 9233 93 9 39 9
% CV 11 133 2 13 11 1 121 2
Measured concentration of RSM in brain homogenate (ng/mL) Mean SD Accu (%)* % CV 39 33 131 11 2 1 9293 19 3 292 12 99 22 33 92 123 22 9 9 122 3 22 99 1 929 3 9 111 912 91 13
CV (precision coeI¿cient oI variation *Accu (accuracy (mean assayed concentration ± nominal concentration (nominal concentration î1
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CONCLUSION
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