Evaluation of metrological characteristics of spectrophotometric quantitative determination of paracetamol in tablets by specific absorbance

O. A. Yevtifieieva, K. I. Proskurina

Abstract


The validation characteristics of the spectrophotometric quantitative determination of paracetamol in tablets by specific absorbance according to the British Pharmacopoeia (BPh) have been evaluated. The results of paracetamol content of 83.59% and 84.39% in terms of the average mass of one tablet do not meet the permissible limits B ±5.0%. The peculiarities of the sample preparation method for quantitative determination of the active pharmaceutical ingredient in tablets has been discussed, and comparative analysis of “Dissolution” and “Assay” tests for paracetamol tablets according to the BPh has been conducted. We have suggested to make such changes at the stage of the sample preparation as “… place the flask in an ultrasonic bath for 30 min…” instead of “…shake for 15 minutes…”. The acceptance criteria of the assay method for paracetamol tablets have been calculated for permissible limits of ±5.0%, ±7.5%, ±10.0%. The results of the convergence and linearity research of the method meet requirements for the permissible limits of ±5.0%. The results of the intermediate precision re-search of the method meet requirements for the permissible limits of ±7.5%. The results of the accuracy research of the method meet requirements for the permissible limits of ±10.0%. Taking into account the technical capabilities of the Ukrainian producers and a diverse list of excipients used in the manufacture of the drug, the spectrophotometric quantitative determination of paracetamol tablets by specific absorbance is recommended to use with the permissible limits of ±10.0%. The prognosis of the total uncertainty of the analysis results is consistent with requirements to the maximum permissible uncertainty of the analysis  Δ10.0%As = 2.6 ≤ max Δ10.0%As= 3.2% and with results of the 3rd round of the Professional Testing Programme (PTP) of “Pharma-test” laboratories in the system of the State Inspection for Medication Quality Control of the Ministry of Public Health of Ukraine.


Keywords


paracetamol; quantitative determination; spectrophotometry; specific absorbance method; validation

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DOI: https://doi.org/10.24959/88947

Abbreviated key title: Vìsn. farm.

ISSN 2415-8844 (Online), ISSN 1562-7241 (Print)