Perbandingan Metode Spektrofotometri UV-Vis dan Kromatografi Cair Kinerja Tinggi dalam Penetapan Disolusi Zolpidem Tartrat

Abstract

Zolpidem tartrat merupakan obat yang sering digunakan dalam mengatasi insomnia. Kontrol kualitas dalam obat penting dilakukan salah satunya dengan pengujian disolusi. Pengujian disolusi zolpidem tartrat lazim menggunakan metode Spektrofotometri UV-Vis berdasarkan USP 43. Seiring dengan pembaruan regulasi, Farmakope Indonesia telah merilis metode KCKT sebagai metode terbaru dalam penetapan disolusi zolpidem tartrat. Oleh karena itu, penelitian bertujuan membandingkan kedua metode tersebut berdasarkan parameter validasi. Hasil validasi kedua metode menunjukkan linearitas dengan R2 = 0,98, akurasi dengan %recovery dalam rentang 95-105%, presisi dengan %RSD < 2%, LOD dan LOQ berada dibawah ambang batas konsentrasi terkecil, dan robustness yang berbeda signifikan akibat kecepatan pengadukan disolusi serta ruggedness memperoleh nilai Fhitung < Ftabel. Hasil uji normalitas dan uji t juga menunjukkan data kedua metode terdistribusi normal dan tidak berbeda signifikan dalam hasil penetapan disolusi. Berdasarkan hasil tersebut metode KCKT dapat diterapkan di PT XY sebagai metode analisis rutin dalam penetapan disolusi zolpidem tartrat

Zolpidem tartrate was a drug that was often used to treat insomnia. Quality control in drugs was important, and one aspect was dissolution testing. Dissolution testing of zolpidem tartrate commonly use the UV-Vis Spectrophotometry method based on USP 43. Along with the regulation, the Indonesian Pharmacopoeia had released the HPLC method as the latest method in determining the dissolution of zolpidem tartrate. Therefore, the study aimed to compare the two methods based on parameter validation. The validation results of both methods showed linearity with R2 = 0.98, accuracy with %recovery in the range of 95-105%, precision with %RSD < 2%, LOD and LOQ were below the smallest concentration threshold, and significantly different resistance due to the speed of dissolution stirring and toughness to obtain Fhitung < Ftabel. The results of the normality test and t-test also showed that the data from both methods were normally distributed and did not differ significantly in the results of dissolution determination. Based on these results, the HPLC method could be implemented at PT XY as a routine analysis method in determining the dissolution of zolpidem tartrate