Validation of the spectrophotometric method for the dosing of some combined capsules
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2024-04-29 12:29
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543.48:615.453.4.012 (1)
Spectral analysis methods. Optical analysis methods (69)
Pharmaceutical preparations. Medical material. Equipment (103)
SM ISO690:2012
UNCU, Livia, EVTODIENCO, Vladilena, MAZUR, Ecaterina, DONICI, Elena, VALICA, Vladimir. Validation of the spectrophotometric method for the dosing of some combined capsules. In: Moldovan Medical Journal, 2021, nr. 4(64), pp. 10-16. ISSN 2537-6373. DOI: https://doi.org/10.52418/moldovan-med-j.64-4.21.02
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Moldovan Medical Journal
Numărul 4(64) / 2021 / ISSN 2537-6373 /ISSNe 2537-6381

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

DOI:https://doi.org/10.52418/moldovan-med-j.64-4.21.02
CZU: 543.48:615.453.4.012

Pag. 10-16

Uncu Livia12, Evtodienco Vladilena1, Mazur Ecaterina1, Donici Elena2, Valica Vladimir12
 
1 Scientific Center of Drug Research,
2 ”Nicolae Testemițanu” State University of Medicine and Pharmacy
 
 
Disponibil în IBN: 21 octombrie 2021


Rezumat

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.

Cuvinte-cheie
dosing, UV-vis spectrophotometry, validation