Simultaneous Determination of Pyrathiazine Theoclate and Pyridoxine HCl by TLC-Densitometry in Commercial Tablets: Validation of the Method

Abstract

A simple and rapid densitometric method has been developed for determination of pyrathiazine theoclate and pyridoxine HCl in commercial tablets. After extracting the samples four times with ethanol, the solutions were spotted on pre-coated silica gel TLC plates, which were eluted with a mixture of dichloromethane–methanol–acetone–acetic acid (19.5:6.0:3.0:1.5, v/v). Quantitative evaluation was performed by measuring the absorbance reflectance of the analyte spots at λ = 254 nm. The TLC-densitometric method is cheap, selective, precise, and accurate and can be used for routine analysis of pyrathiazine theoclate and pyridoxine HCl in tablet preparations at industry quality control laboratories.

Keywords:

• Densitometry
• Parathiazine theoclate
• Pyrathiazine theoclate
• Pyridoxine HCl
• Tablets
• TLC
• Validation

ACKNOWLEDGMENT

The authors are very grateful to Mr. Fajar Zulkarnain Lubis (Assessment, Service Unit, Faculty of Pharmacy, Airlangga University) for preparing the figures.

Notes

^a % of label claim.

^b X_f and X_c are, respectively, the measured and theoretical nominal amount of the analyte spotted (ng spot⁻¹).

^c For p = 0.05.

^d n = 3.

^e n = 2 × 4 levels = 8.

^f n = 3 × 3 levels = 9.

^a Intermediate Precision Evaluation.

^b Each measurement was performed by a different analyst on the different days, and plates within one laboratory.

^c Repeatability Evaluation.

^d % of Label Claim.

^a Mobile phase composition presented in v/v.

^b Mean value of triplicate determinations.

^a Calculated from data presented on Table 3.

^b Calculation was performed by using Unscrambler 9.6 software (CAMO).

^c Probability value.

NS means Not Significant and S Means Significant (for p = 0.05).

^a Purity and Identity checks of analyte spots using CATS software yielded very good values (r > 0.999).