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Journal of Industrial and Environmental Chemistry| Volume: 3
February 18-19, 2019 | Paris, France
Joint Event
Green Chemistry and Technology
8
th
World Congress on
International Conference on
Organic and Inorganic Chemistry
T
he aimof this study was to validate swab and rinse sampling
procedures and developed HPLC method for quantitative
estimation of residues of alprazolam residues in cleaning
control samples collected from pharmaceutical equipment
surfaces after manufacturing of alprazolam 1 mg uncoated
tablets. The swab and rinse sampling procedures were
developed and qualified in order to obtain a suitable and good
recovery (>90 %). The known amounts of alprazolam at three
different concentration levels are spiked onto representative
surfaces, which are disinfected and cleaned, then dried,
sampled using swabbing and rinsing. The samples were
analyzed using the validated HPLC method. For swab sampling
the surface (sampling area-25cm
2
) was successively wiped
with one micro polyester swab (3Ч2.5Ч10mm) moistened
with diluent – methanol. The influence of swab material on
quantitative determination of alprazolam was checked as well.
The HPLC was developed using LC system “Ag 1260 Infinity”
and Prodigy C8(2) 250 Ч 4.0mm, 5μm column with a mobile
phase - a mixture of methanol, phosphate buffer pH 3.0 and
acetonitrile (10 : 45 : 45 v/v); The flow rate–1.4mL/min; The
detector wavelength-220nm; The injection volume–20 μL;
The column temperature–300
o
C. The method was validated
with respect to robustness, system suitability test, specificity,
linearity-range, accuracy, precision (intra-day and inter day),
limit of detection (LOD) and quantitation (LOQ). The solutions
stability and 0.45 μm membrane filter compatibility were
studied as well. These studies were performed in accordance
with established ICH Q2 guideline. The calibration curve
is linear (r
2
=1.00000) over a wide concentration range
0.0075–10μg/mL; LOQ-0.0075μg/mL and LOD-0.005μg/mL.
The method can be applied to determine quantitatively
alprazolam residues in test solutions with very low
concentrations below the acceptable concentration of the
cross-contamination limit.
Speaker Biography
Imeda Rubashvili has completed his PhD at the age of 28 years from Georgian Technical
University and postdoctoral study from the University of Liege. He is a senior scientific
researcher at Petre Melikishvili Institute of physical and Organic Chemistry of Ivane
Javakhishvili Tbilisi State University, a visiting lecturer in several local universities and
head of validation department of pharmaceutical company “Aversi-Rational” Ltd. He
has published more than 30 scientific papers in reputed peer-reviewed journals and
has been serving as an editorial board member and a reviewer. He is the member
of the council of young scientists of the Georgian National Academy of Sciences.
e:
rubashvili@yahoo.frImeda Rubashvili
Tbilisi State University, Georgia
Development and validation of sampling procedures and quantitative determination
HPLC methods of active pharmaceutical ingredient - Alprazolam residues on
pharmaceutical technological equipment
Imeda Rubashvili, J Ind Environ Chem 2019, Volume 3
DOI: 10.4066/2591-7331-C1-007