Validation of the spectrophotometric method for the dosing of some combined capsules

Abstract

Background: UV-Vis spectrophotometry remains the most accessible spectral method with a high degree of sensitivity and information. The advantage of the method consists in its universality, the ability to combine with other methods, the minimum error, as well as its economic efficiency. The objective of this study was the determination of some validation parameters for the spectrophotometric method of dosing piracetam and nicergoline in combined capsules. Material and methods: Agilent 8453 UV-Vis spectrophotometer, reference standards of piracetam and nicergoline, 0.1 M HCl methanolic solution. Validation of the spectrophotometric method according to the requirements of the ICH guide “Q2R1: For analytical procedures and validation”. Results: Linearity was investigated on concentration ranges 5-40 µg / mL. The regression (R2 ) values were 0.9998 for nicergoline and 0.998 for piracetam, respectively. The limit of detection was 1.737 µg / mL for nicergoline and 0.369 µg / mL for piracetam. Quantification limit values were also calculated as 5.265 and 1.118 µg / mL for nicergoline and piracetam, accordingly. The results obtained showed that the developed spectrophotometric method is accurate, precise and robust, because the value of the relative standard deviation was less than 1.0%. Conclusions: The developed spectrophotometric method showed specificity, linearity, accuracy, precision and robustness, and can be applied on the concentration range between 80-120% of the nominal value of the content of nicergoline and piracetam in the preparation.

Keywords

• dosing
• uv-vis spectrophotometry
• validation.