{"id":11630,"date":"2025-10-09T16:51:00","date_gmt":"2025-10-09T09:51:00","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=11630"},"modified":"2025-10-09T16:52:26","modified_gmt":"2025-10-09T09:52:26","slug":"dexamethasone-sodium-phosphate-eye-drops-solution","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/dexamethasone-sodium-phosphate-eye-drops-solution\/","title":{"rendered":"Dexamethasone Sodium Phosphate Eye Drops, Solution"},"content":{"rendered":"

Edition: BP 2025 (Ph. Eur. 11.6 update)<\/span><\/p>\n

General Notices<\/span><\/p>\n

Action and use<\/b><\/p>\n

Glucocorticoid.<\/span><\/p>\n

DEFINITION<\/span><\/h2>\n
Dexamethasone Sodium Phosphate Eye Drops, Solution are a sterile Solution of Dexamethasone Sodium Phosphate in a suitable vehicle.<\/span><\/p>\n
The eye drops comply with the requirements stated under Eye Preparations and with the following requirements.<\/span><\/i><\/p>\n
Content of dexamethasone sodium phosphate, C_{22<\/sub>H_{28<\/sub>FNa_{2<\/sub>O_{8<\/sub>P<\/b><\/p>\n}}}}
95.0 to 105.0% of the stated amount.<\/span><\/p>\n
IDENTIFICATION<\/span><\/h2>\n
Mix a quantity of the eye drops containing 20 mg of Dexamethasone Sodium Phosphate with 5 mL of 0.1M sodium hydroxide, add 50 mL of dichloromethane and mix with the aid of ultrasound for 20 minutes, filter the dichloromethane layer and evaporate to dryness using a rotary evaporator. Dry the residue at 105\u00b0 for 2 hours. The infrared absorption spectrum of the dried residue, Appendix II A, is concordant with the reference spectrum of dexamethasone (RS 089).<\/span><\/p>\n
TESTS<\/span><\/h2>\n
Alkalinity<\/span><\/h3>\n
pH, 7.0 to 7.5, Appendix V L.<\/span><\/p>\n
Related substances<\/span><\/h3>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.<\/span><\/p>\n
(1) Disperse a quantity of the eye drops containing 20 mg of Dexamethasone Sodium Phosphate in 70 mL, mix with the aid of ultrasound for 10 minutes, dilute to 100 mL and filter.<\/span><\/p>\n
(2) Dilute 3 volumes of solution (1) to 100 volumes.<\/span><\/p>\n
(3) 0.02% w\/v of dexamethasone impurity standard BPCRS.<\/span><\/p>\n
(4) Dilute 1 volume of solution (1) to 100 volumes and dilute 1 volume of this solution to 10 volumes<\/span><\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/span><\/h4>\n
(a) Use a stainless steel column (15 cm X 3.9 mm) packed with octadecylsilyl silica gel for chromatography R (5 pm) (Waters Symmetry C18 is suitable).<\/span><\/p>\n
(b) Use isocratic elution and the mobile phase described below.<\/span><\/p>\n
(c) Use a flow rate of 1.5 mL per minute.<\/span><\/p>\n
(d) Use an ambient column temperature.<\/span><\/p>\n
(e) Use a detection wavelength of 254 nm.<\/span><\/p>\n
(f) Inject 50 pL of each solution.<\/span><\/p>\n
(g) For solution (1), allow the chromatography to proceed for six times the retention time of dexamethasone sodium phosphate.<\/span><\/p>\n
MOBILE PHASE<\/span><\/h4>\n
27 volumes of acetonitrile and 73 volumes of a 0.3% w\/v solution of orthophosphoric acid that has been previously adjusted to pH 3.0 with 2M sodium hydroxide.<\/span><\/p>\n
SYSTEM SUITABILITY<\/span><\/h4>\n
The test is not valid unless, in the chromatogram obtained with solution (3):<\/span><\/p>\n
the resolution factor between the peaks due to impurity 3 and dexamethasone is at least 1.5;<\/span><\/p>\n
the chromatogram closely resembles the chromatogram supplied with dexamethasone impurity standard BPCRS.<\/span><\/p>\n
LIMITS<\/span><\/h4>\n
In the chromatogram obtained with solution (1):<\/span><\/p>\n
the sum of the areas of any secondary peaks is not greater than the area of the peak in the chromatogram obtained with solution (2) (3%).<\/span><\/p>\n
Disregard any peak with an area less than the area of the peak in the chromatogram obtained with solution (4) (0.1%).<\/span><\/p>\n
ASSAY<\/span><\/h2>\n
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in the mobile phase.<\/span><\/p>\n
(1) Disperse a quantity of the eye drops containing 20 mg of Dexamethasone Sodium Phosphate in 70 mL, mix with the aid of ultrasound for 10 minutes, dilute to 100 mL and filter.<\/span><\/p>\n
(2) 0.015% w\/v of dexamethasone BPCRS.<\/span><\/p>\n
(3) 0.02% w\/v of dexamethasone impurity standard BPCRS.<\/span><\/p>\n
CHROMATOGRAPHIC CONDITIONS<\/span><\/h3>\n
The chromatographic conditions described under Related substances may be used.<\/span><\/p>\n
SYSTEM SUITABILITY<\/span><\/h3>\n
The test is not valid unless, in the chromatogram obtained with solution (3):<\/span><\/p>\n
the resolution factor between the peaks due to impurity 3 and dexamethasone is at least 1.5;<\/span><\/p>\n
the chromatogram closely resembles the chromatogram supplied with dexamethasone impurity standard BPCRS.<\/span><\/p>\n
DETERMINATION OF CONTENT<\/span><\/h3>\n
Calculate the content of C_{22<\/sub>H_{28<\/sub>FNa_{2<\/sub>O_{8<\/sub>P in the eye drops using the declared content of C_{22<\/sub>H_{29<\/sub>FO_{5<\/sub> in dexamethasone BPCRS. Each mg of C_{22<\/sub>H_{29<\/sub>FO_{5<\/sub> is equivalent to 1.3157 mg of C_{22<\/sub>H_{28<\/sub>FNa_{2<\/sub>O_{8<\/sub>P.<\/span><\/p>\n}}}}}}}}}}}}}}
STORAGE<\/span><\/h2>\n
Dexamethasone Sodium Phosphate Eye Drops should be stored in accordance with the manufacturer\u2019s instructions.<\/span><\/p>\n
IMPURITIES<\/span><\/h2>\n
$\"dexamethasone-sodium-phosphate-eye-drops-solution\"$ <\/span><\/p>\n
1. dexamethasone-17\u03b2-carboxylic acid,<\/span><\/p>\n
$\"dexamethasone-sodium-phosphate-eye-drops-solution\"$ <\/span><\/p>\n
2. dexamethasone-17\u03b1-dehydroxy-17\u03b2-carboxylic acid,<\/span><\/p>\n
$\"dexamethasone-sodium-phosphate-eye-drops-solution\"$ <\/span><\/p>\n
3. dexamethasone-21-aldehyde,<\/span><\/p>\n
$\"dexamethasone-sodium-phosphate-eye-drops-solution\"$ <\/span><\/p>\n
4. dexamethasone-17-ketone,<\/span><\/p>\n
$\"dexamethasone-sodium-phosphate-eye-drops-solution\"$ <\/span><\/p>\n
5. dexamethasone-17(20)-enol-21-aldehyde.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"
Edition: BP 2025 (Ph. Eur. 11.6 update) General Notices Action and use Glucocorticoid. DEFINITION Dexamethasone Sodium Phosphate Eye Drops, Solution are a sterile Solution of Dexamethasone Sodium Phosphate in a suitable vehicle. The eye drops comply with the requirements stated under Eye Preparations and with the following requirements. Content of dexamethasone sodium phosphate, C22H28FNa2O8P 95.0…<\/p>\n","protected":false},"author":5,"featured_media":11631,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-11630","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/11630","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=11630"}],"version-history":[{"count":3,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/11630\/revisions"}],"predecessor-version":[{"id":11641,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/11630\/revisions\/11641"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/11631"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=11630"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=11630"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=11630"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}