DEVELOPMENT AND VALIDATION OF A MODIFIED POLARIMETRIC ASSAY METHOD FOR SMALL VOLUME SAMPLES

  • K. C. Ajithkumar College of Pharmaceutical Sciences, Govt. Medical College, Kozhikode – 673008, Kerala, India
  • K. Pramod College of Pharmaceutical Sciences, Govt. Medical College, Kozhikode – 673008, Kerala, India

Abstract

Objective: The objective of the present work was to develop a method to be useful for analyzing small volume samples of an optically active compound.

Methods: The method employed quartz cuvette instead of a polarimeter tube. Quantification of optically active compound was successfully validated in terms of linearity and range, precision and robustness. The detection limit (DL) and quantitation limit (QL) were determined as per the ICH guidelines.

Results: Polarimetry generally involves the quantification of optically active compounds by measuring its ability to rotate (in terms of angle of rotation) polarized light passed through it. The plot of angle of rotation versus concentration was linear in wide range of concentration with excellent coefficient of determination of 0.9989±0.0008. The low values of % relative standard deviation (RSD) for repeatability and intermediate precision suggested an excellent precision of the developed polarimetric method. The detection limit (DL) and quantitation limit (QL) were determined were found to be 0.5025 and 1.5225 %w/v respectively.

Conclusion: A modified polarimetric method for the quantification of dextrose was successfully developed and validated. The method employed quartz cuvette instead of polarimeter tube. The method is expected to be useful in a variety of industries where dextrose finds its application. The method can also be extended to other optically active compounds.

Keywords: ICH, Linearity, Optical activity, Range, Precision, Robustness, Detection limit, Quantitation limit

References

1. Yuan A, De-jiang S. Polarimetric assay of netilmicin sulfate eye drops. Chin J Pharm Anal 2005;25:986-7.
2. Purvinis G, Cameron BD, Altrogge DM. Noninvasive polarimetric-based glucose monitoring: an in vivo study. J Diabetes Sci Technol 2011;5:380-7.
3. Blass DA, Adams E. Polarimetry as a general method for enzyme assays. Anal Biochem 1976;71:405-14.
4. ICH-Guidelines Q2 (R1). Validation of analytical procedures: text and methodology. Geneva, Switzerland: 2005.
Statistics
161 Views | 462 Downloads
How to Cite
Ajithkumar, K., & Pramod, K. (2017). DEVELOPMENT AND VALIDATION OF A MODIFIED POLARIMETRIC ASSAY METHOD FOR SMALL VOLUME SAMPLES. International Journal of Applied Pharmaceutics, 9(6), 91-94. https://doi.org/10.22159/ijap.2017v9i6.22459
Section
Original Article(s)