Spectrophotometric determination of amoxicillin in pharmaceutical formulations

Özet

Bu qahsmada, amoksisilin’in farmasötik preparatlarda miktar tayini için uq yeni spektrofotometrik yöntem, orijinal UV spektrofotometri, birinci ve ikinci türev spektrofotometri, geliştirilmiştir. Orijinal UV spektrofotometride absorbans değerleri, amoksisilin in O.lN NaOH iqerisindeki qözeltilerinin 220-350 nm arahgindaki UV spektrumlarında 247.0 nm de ölqulmustür. Birinci türevUV spektrofotometride, dA/dl değerleri, amoksisilin in 0.1N NaOH iqerisindeki qözeltilerinin 220-320 nm arahgindaki birinci türev UV spektrumlarında (AX= 2 nm) 255.8 nm de ölqulmustür. İkinci türev UV spektrofotometride cfA/dl2 değerleri amoksisilin in O.lN NaOH iqerisindeki qözeltilerinin 220-320 nm arahgindaki ikinci türev UV spektrumlarında (AX= 4 nm) 255.8 nm de ölqülmustür. Qahsmada doğrusal qahsma araligi her üq yöntem iqin de 3.2 - 48.0 jUg/mL olarak bulunmuştur. Yöntemlerdeki ortalama geri kazanım ve bagil standart sapma değerleri sırasıyla orijinal UV spektrofotometride 247.0 nm de % 99.67 ve % 1.20, birinci türev UV spektrofotometride,255.8 nm de % 99.04 ve % 1.74 ve, ikinci türev UV spektrofotometride249.2 nm de % 99.43 ve % 2.35 olarak bulunmuştur. Geliştirilen uq yöntem Türkiye ilaq piyasasında bulunan 8 adet tablet, 2 adet oral suspansiyon ve bir adet liyofilize toz formulasyonuna başanyla uygulanmistır. Elde edilen türn sonuqlar USP XXII de belirtilen yöntemlerle elde edilenlerle istatistiksel olarak karsilaştinlmistır.

Abstract

In present study, three new spectrophotometric methods, original UV spectrophotometry, first and second order derivative UV spectrophotometry, were developed for the determination of amoxicillin in pharmaceutical preparations. In original UV spectrophotometry, absorbances were measured at 247.0 nm in the zero order UV spectra of the solution of amoxicillin in O.lN NaOH in the range of 220 - 350 nm. In first derivative UV spectrophotometry, dA/dl values were measured at 255.8 nm in the first derivative UV spectra of the solution of amoxicillin in O.lN NaOH in the range of 220 -320 nm (AX= 2 nm). In second derivative UV spectrophotometry cfA/dl2 values were measured at 249.2 nm in the second derivative UV spectra of the solution of amoxicillin in O.lN NaOH in the range of 220 - 320 nm (AX= 4 nm). Linearity range was found as 3.2 - 48.0 jUg/mL in all three methods. Mean recoveries and the relative standard deviations of the methods were found as 99.67 % and 1.20 % in original UV spectrophotometry at 247.0 nm, 99.04 % and 1.76 % in first derivative UV spectrophotometry at 255.8 nm and, 99.43 % and 2.34 % in second derivative UV spectrophotometry at 249.2 nm respectively. Three spectrophotometric methods developed were successfully applied to 8 tablets, 2 oral suspensions and 1 lyophilized powder formulation commercially available in Turkish drug market. All the results were compared statistically with those obtained by using the methods indicated in USP XXIII.