Ketorolac Tromethamine CAS 74103-07-4 Ịdị ọcha>99.0% (HPLC)

Ketorolac Tromethamine nwere ọ bụghị ihe na-erughị 98.5 pasent na ọ bụghị karịa 101.5 pasent nke C15H13NO3 · C4H11NO3, gbakọọ na akpọnwụwo ndabere.
Nkwakọ ngwaahịa na nchekwa - Chekwaa n'ime akpa siri ike, enweghị ọkụ.Chekwaa na 25°, njem nlegharị anya kwere n'etiti 15° na 30°
Ụkpụrụ ntụaka USP <11>-
USP Ketorolac Tromethamine RS
njirimara-
A: Infrared absorption <197K>.
B: Mmetụta Ultraviolet <197U>-
Ngwọta: 10 μg kwa ml
Ọkara: methanol.
C: Tromethamine test-Kwadebe ihe ngwọta ọkọlọtọ nke USP Ketorolac Tromethamine RS na ngwakọta nke dichloromethane na methanol (2: 1) nwere 5 mg kwa ml.N'otu aka ahụ, kwadebe ngwọta nnwale nke Ketorolac Tromethamine nwere 5 mg kwa ml.Tinye mpịakọta 40-µL nke ọkọlọtọ ọkọlọtọ na ngwọta nnwale na efere chromatographic dị mkpa (lee Chromatography <621>) nke ejiri akwa 0.25-mm nke ngwakọta silica chromatographic kpuchiri.Tinye efere ahụ n'ime ụlọ chromatographic nke jikọtara ya na ngwakọta dichloromethane, acetone, na glacial acetic acid (95:5:2).Mechie ọnụ ụlọ ahụ, ma mepụta chromatogram ruo mgbe ihu ihe mgbaze emegharịla ihe dị ka ụzọ atọ n'ụzọ anọ nke ogologo efere ahụ.Wepu efere ahụ n'ime ụlọ ahụ, ma kwe ka ihe mgbaze na-ekpochapụ.Fesa efere ahụ na ngwọta mmanya a kwadebere ọhụrụ nke nwere 30 mg nke ninhydrin kwa ml, wee kpoo efere ahụ n'ihe dịka 150 ° maka nkeji 2 ruo 5.Ebe odo na-acha odo odo na-acha odo odo na-acha odo odo na-etolite na efere na mpaghara ebe a na-etinye ihe ngwọta Standard na ngwọta ule.
pH <791>: n'etiti 5.7 na 6.7, na ngwọta (1 na 100).
Ọnwụ na ihicha <731>-Kọchaa ya na agụụ na 60 Celsius maka awa 3: ọ na-efunahụ ihe karịrị 0,5% nke ibu ya.
Ihe fọdụrụ na mgbanye <281>: ọ bụghị karịa 0.1%.
Ọla dị arọ, Usoro II <231>: 0.002%.
Chromatographic ịdị ọcha-
Usoro mkpanaaka, ngwakọta ihe mgbaze, nkwadebe ọkọlọtọ, ngwọta mkpebi, yana sistemụ Chromatographic-Gaa n'ihu dị ka enyere ya na nyocha.
Ngwọta nwale-Jiri nkwadebe Assay.
Usoro-Chromatograph Ngwọta Nnwale dị ka akwadoro maka Usoro dị na Assay, na-enye ohere ka chromatography gbatịkwuo oge nke ketorolac ugboro atọ.Tulee nzaghachi nke ọnụ ọgụgụ kacha elu niile.Gbakọọ pasent nke adịghị ọcha onye ọ bụla na mpaghara Ketorolac Tromethamine nke usoro a were were:
100rfi (ri / rs)
nke rfi bụ ihe nzaghachi nke ọnụ ọgụgụ adịghị ọcha nke onye ọ bụla metụtara nke ketorolac;ri bụ nzaghachi kacha elu maka adịghị ọcha ọ bụla;na rs bụ nchikota nke nzaghachi kachasị elu nke ọnụ ọgụgụ adịghị ọcha na isi ketorolac.Ụkpụrụ rfi bụ 0.52 maka ketorolac 1-keto analọgụ, 0.67 maka ketorolac 1-hydroxy analọg, 2.2 maka adịghị ọcha na-enwe oge njide nke 0.54 n'ihe gbasara nke ketorolac, na 0.91 maka adịghị ọcha na oge njigide. nke 0.66.Achọpụtaghị ihe karịrị 0.1% nke ketorolac 1-keto analọgụ ma ọ bụ nke analọgụ ketorolac 1-hydroxy;erughị 0.5% nke adịghị ọcha ọ bụla a hụrụ;na nchikota nke adịghị ọcha niile abụghị ihe karịrị 1.0%.
Nyocha -
Usoro mkpanaaka-Kwụsa 5.75 g nke monobasic ammonium phosphate na 1000 ml mmiri, ma dozie ya na phosphoric acid ka ọ bụrụ pH nke 3.0.Kwadebe ngwakọta akọrọ na degassed nke ngwọta nchekwa a na tetrahydrofuran (70:30).Mee mgbanwe ma ọ bụrụ na ọ dị mkpa (lee Dabara Sistemu n'okpuru Chromatography <621>) iji nweta oge njide maka ketorolac ihe dịka nkeji 8 ruo 12.
Ngwakọta mgbaze- Kwadebe ngwakọta nke mmiri na tetrahydrofuran (70:30).
Nkwadebe ọkọlọtọ-N'ụzọ zuru ezu gbazee ọnụọgụ USP Ketorolac Tromethamine RS nke ọma na ngwakọta Solvent iji nweta ihe ngwọta na-enwe mkpokọta amara nke ihe dịka 0.4 mg kwa ml.[IHE-Chebe ngwọta a n'ìhè.]
Nkwadebe nyocha - Nyefee ihe dịka 20 mg nke Ketorolac Tromethamine, nke a tụrụ nke ọma, gaa na flask volumetric 50-mL, gbanye ya na ngwakọta Solvent na olu, ma gwakọta ya.[IHE-Chebe ngwọta a n'ìhè.]
Ngwọta mkpebi - Na ihe nkesa 250-mL na-ejikọta 100 ml mmiri, 100 ml dichloromethane, 30 mg nke USP Ketorolac Tromethamine RS, na 1 ml nke 1 N hydrochloric acid.Fanye ihe nkwụsịtụ, maa jijiji, ma kwe ka ọkwa ndị ahụ kewaa.Nyefee oyi akwa dichloromethane dị ala na iko borosilicate kwụsịrị, ma tụfuo oyi akwa nke elu.Wepụ ihe ngwọta dichloromethane na ìhè anyanwụ na-eduzi maka nkeji 10 ruo 15.Nyefee 1.0 ml nke ngwọta na vial, kpochapu na ikuku dị ugbu a ma ọ bụ na iyi nke nitrogen ka nkụ, tinye 1.0 ml nke ngwakọta Solvent, ma tụgharịa ka ọ gbazee.[IHE-Enwere ike ịchekwa ngwọta a n'okpuru refrigeration ma jiri ya mee ihe ọ bụrụhaala na chromatogram enwetara dị ka ntuziaka maka Usoro dabara adaba maka ịchọpụta ọnụ ọgụgụ kachasị elu n'ihi ketorolac 1-keto analọg na ketorolac 1-hydroxy analog, yana maka nha mkpebi ahụ. n'etiti ketorolac 1-keto analọgụ na ketorolac.]
Usoro Chromatographic (lee Chromatography <621>)) -Kromatograph mmiri mmiri nwere ihe nchọta 313-nm yana kọlụm 4.6mm × 25-cm nke nwere ngwugwu 5-µm L7 ma na-edobe ya na okpomọkụ na-adị ihe dị ka 40º.Onu ogugu a bu ihe dika 1.5 ml kwa nkeji.Chromatograph the Resolution solution, wee dekọọ nzaghachi kacha elu dị ka akwadoro maka Usoro: oge ​​njide ikwu bụ ihe dịka 0.63 maka analọgụ ketoroac 1-hydroxy, 0.89 maka ketorolac 1-keto analọgụ, yana 1.0 maka ketorolac;na mkpebi, R, n'etiti ketorolac 1-keto analọgụ na ketorolac abụghị ihe na-erughị 1.5.Chromatograph the Standard nkwadebe, na dekọọ nzaghachi kacha elu dị ka eduzi maka Usoro: arụmọrụ kọlụm erughị 5500 theoretical plates;na ndị ikwu ọkọlọtọ ndiiche maka oyiri injections abụghị ihe karịrị 1.5%.
Usoro-iche iche nha nha nha (ihe dị ka 10 µL) nke nkwadebe ọkọlọtọ na nkwadebe Assay n'ime chromatograph, dekọọ chromatogram, wee tụọ azịza maka ọnụ ọgụgụ ndị bụ isi.Gbakọọ ọnụọgụ, na mg, nke C15H13NO3 · C4H11NO3 na akụkụ Ketorolac Tromethamine nke usoro a were were:
50C (rU / rS)
nke C bụ ntinye uche, na mg kwa ml, nke USP Ketorolac Tromethamine RS na nkwadebe Standard;na rU na rS bụ nzaghachi elu ketorolac enwetara site na nkwadebe Assay na nkwadebe Standard, n'otu n'otu.