The method of HPLC fingerprint analy

The method of HPLC fingerprint analysis was validated in terms of precision, repeatability and stability test.
Intraday precision and repeatability as well as interday stability of the HPLC fingerprint method were determined and expressed by the relative standard deviations (RSD) value of the average relative retention times (RRT) and relative peak areas (RPA) of the 13 characteristic common peaks with the respect to the reference peak (peak 6) at retention time (tR) of 19.933 min.
By using the optimised conditions described above, the repeatability of the HPLC method was calculated by analysing five independently prepared solutions of the same sample (Sample 1).
The variation of RRT and RPA of the characteristic peaks did not exceed 1% and 3%, respectively.
The intraday precision variation of the RRT and RPA of the characteristic peaks was below 1% and 3%, respectively, by analysing the five replicate sample solutions (Sample 1) continuously on the same day.
The interday stability test was assessed by analysing the same sample solution (Sample 1) on two consecutive days at different time intervals (0, 6, 12, 24, and 48 h) and the RSD values of RRT as well as RPA of the characteristic common peaks were less than 1% and 3%, respectively.
The observed results indicated that the sample solution was stable within 48 h.
The results of the precision, stability and repeatability are shown in Table 2, which met the national standard of traditional Chinese medicine fingerprint (SFDA, 2000).

Hasil (Bahasa Indonesia) 2:

Metode HPLC analisis fi ngerprint divalidasi dalam hal presisi, pengulangan dan uji stabilitas.
Presisi Intraday dan pengulangan serta stabilitas interday dari metode fi ngerprint HPLC ditentukan dan diungkapkan oleh standar deviasi relatif (RSD) nilai rata-rata retensi relatif kali (RRT) dan luas puncak relatif (RPA) dari 13 puncak karakteristik umum dengan hormat ke puncak referensi (peak 6) pada waktu retensi (tR) dari 19,933 menit.
Dengan menggunakan kondisi optimal dijelaskan di atas, pengulangan dari Metode HPLC dihitung dengan menganalisis lima solusi independen siap dari sampel yang sama (Contoh 1).
Variasi RRT dan RPA puncak karakteristik tidak melebihi 1% dan 3%, masing-masing.
Variasi intraday presisi dari RRT dan RPA dari puncak karakteristik di bawah 1% dan 3%, masing-masing, dengan menganalisis fi ve meniru solusi sampel (Contoh 1) terus menerus pada hari yang sama.
Uji stabilitas interday dinilai dengan menganalisis larutan sampel yang sama (Contoh 1) pada dua hari berturut-turut pada interval waktu yang berbeda (0, 6, 12, 24, dan 48 jam) dan nilai-nilai RSD dari RRT serta RPA dari puncak karakteristik umum kurang dari 1% dan 3%, masing-masing.
Hasil pengamatan menunjukkan bahwa sampel solusi stabil dalam waktu 48 jam.
Hasil presisi, stabilitas dan pengulangan ditunjukkan pada Tabel 2, yang memenuhi standar nasional Cina tradisional obat fi ngerprint (SFDA, 2000).