The use of surrogate reference standard in Quantitative HPLC: A case study of Albendazole and Quinine sulphate tablets
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Date
2015-04-24
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Abstract
A simple, fast and a sensitive Reverse-phase HPLC method was developed for the
quantitative analysis of Albendazole and Quinine Sulphate tablets using Aspirin,
Amoxicillin Trihydrate and Metronidazole as surrogate reference standards.
For the assay of Albendazole tablets, a C-18 waters 4.6 x 150mm column (stationary phase)
and a mobile phase made of Methanol -Water (60:40
V
/v) at pH of 5.40±0.02 was used. The
analysis was carried out at 245nm and flow rate of 1ml/min. The mean retention time of
Albendazole, Aspirin, Amoxicillin Trihydrate and Metronidazole were; 4.21±0.036min,
1.74±0.021min, 2.53±0.018min and 2.28±0.027min respectively. When Aspirin was used as
a surrogate reference standard, the constant ‘K’ obtained was 2.297±0.004 and the average
percentage content of Albendazole in the Alben, Wormplex 400 and the Zeben tablets after
five determinations were; 98.22±0.66%, 101.63±0.587% and 98.82±0.535% respectively.
When Amoxicillin Trihydrate was used as a surrogate reference standard, the ‘K’ value
obtained was 2.693±0.009 and the average percentage content of Albendazole in the Alben,
Wormplex 400 and the Zeben tablets after five determinations were; 99.55±0.675%,
101.02±0.639% and 99.79±0.824% respectively. When Metronidazole was used as a
surrogate reference standard, the ‘K’ obtained was 1.827±0.003 and the average percentage
content of Albendazole in the Alben, Wormplex 400 and Zebe n tablets were 99.37±0.84,
101.13±0.500 and 99.82±0.577 respectively.
A C-18 waters 4.6 x 150mm column, mobile phase combination of Methanol -Water (60:40
V
/v) with the pH adjusted to 5.20±0.02 were employed for the analysis of Quinine Sulphate
tablets, wavelength of detection was 245nm, and flow rate was 1.5ml/min. Quinine Sulphate,
Aspirin, Amoxicillin Trihydrate and Metronidazole had average retention time of
v
6.65±0.015min, 2.78±0.03min, 3.02±0.017min and 2.02±0.007 min respectively. When
Aspirin was used as a surrogate reference standard, the ‘K’ value obtained was 2.549±0.007
and the percentage content of Quinine Sulphate in the Actavis, Co -Pharma and the Wockhardt
tablets were; 98.57±0.89%, 102.74±0.64% and 98.18±0.75% respectively. When
Amoxicillin Trihydrate was used as a surrogate reference standard, the ‘K’ value obtained
was 3.893±0.008 and the average percentage content of Quinine Sulphate in the Actavis, Co -Pharma and the Wockhardt tablets were 99.99±0.43%, 101.84±0.44% and 97.004±0.62%
respectively. When Metronidazole was used as a surrogate reference standard, the ‘K’ value
obtained was 1.034±0.006 and the average percentage content of Quinine Sulphate in the
Actavis, Co-Pharma and the Wockhardt tablets were 99.87±0.42%, 103.22±0.38% and
100.17±0.399% respectively.
The results obtained from the developed method were statistically comparable to results
obtained from the standard methods. The developed method showed good precision, was
robust and linear within the working range, thus making the deve loped methods very suitable
for quantification of Albendazole and Quinine Sulphate tablets.
Description
A thesis submitted in partial fulfillment of the
requirement for the degree of
Master of Philosophy
(Pharmaceutical Chemistry).