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Dushyant Patel Summary and Conclusion

S.K.P.C.P.E.R., Kherva 79 M .Pharm. Thesis

CHAPTER 6: SUMMARY AND CONCLUSION

6.1 SUMMARY:

¾ Methods including LC-MS/MS, GC-MS, HPLC, HPTLC, Capillary Electrophoresis,

colorimetric methods were reviewed for the estimation of GBP in biological fluids and

pharmaceutical formulations.

¾ LC-MS/MS method for estimation of GBP in human plasma was developed.

¾ The developed LC-MS/MS method was validated for linearity, accuracy, interday and

intraday precision, matrix effect, dilution integrity, freeze and thaw stability, stock

solution stability, recovery, bench top stability, process stability.

¾ Extractive spectrophotometric methods based on formation of ion pair between GBP and

dyes were developed using BCG and BTB dye.

¾ Dye, pH of buffer, volume of buffer, volume of dye was optimized to get maximum

absorbance of resulting solution.

¾ The developed extractive spectrophotometric methods were validated for linearity, limit

of detection, limit of quantification, recovery (accuracy), reproducibility, interday and

intraday precision.

¾ Finally the developed validated extractive spectrophotometric methods were applied in

pharmaceutical dosage forms including capsule and tablets.

6.2 CONCLUSION:

6.2.1 LC-MS/MS METHOD:

¾ The results of the method validation for GBP indicated that the analytical method was

valid for the analysis of GBP with a calibration range of 0.05 µg/ml to 6.00 µg/ml in

human plasma using LEV as internal standard.

¾ From results of matrix effect, it was concluded that the method can be used for

estimation of GBP in human plasma without any interferences of biological matrix.

6.2.2 EXTRACTIVE SPECTROPHOTOMETRIC METHODS:

¾ During the course of study, it was observed that acidic solution of the drug formed

colored ion-association complexes with BCG and BTB which were soluble in

chloroform. This property of the drug was followed for the development of extractive

spectrophotometric methods for analysis of drug. The complex of GBP with BCG and

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