USP34–NF29 Nevirapine Oral Suspension.docVIP

Nevirapine Oral Suspension ? Nevirapine Oral Suspension contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of nevirapine (C15H14N4O). Packaging and storage— Preserve in well-closed containers. Store at 25, excursions permitted between 15 and 30. USP Reference standards 11— USP Nevirapine Anhydrous RS . USP Nevirapine Related Compund A RS. USP Nevirapine Related Compound B. Identification— A: Thin-Layer Chromatographic Identification Test 201— Ferric chloride–potassium ferricyanide reagent— Dissolve 1.35 g of ferric chloride in 25 mL of water. Dissolve 1.64 g of potassium ferricyanide in 25 mL of water. Mix the two solutions immediately before use. Test solution— Transfer a volume of Oral Suspension, equivalent to about 10 mg of nevirapine, to an 8-mL glass stoppered tube. Pipet 2.0 mL of chloroform into the tube, and shake. Allow the two phases to separate, and then using a disposable glass Pasteur pipet, remove some of the organic layer from the bottom, and transfer to another container. Standard solution— Dissolve a suitable quantity of USP Nevirapine Anhydrous RS in chloroform to obtain a solution having a known concentration of about 5 mg per mL. Procedure— Separately apply 5-μL portions of the Test solution and the Standard solution to a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel 60 F254. Allow the spots to dry, and develop the chromatogram in a chamber saturated with a solvent system consisting of a mixture of ethyl acetate, isopropanol, and concentrated ammonium hydroxide (18:2:0.1) until the solvent front has moved about 6 to 7 cm from the point of application. Remove the plate from the chamber, mark the solvent front, and dry. Examine the chromatograms under UV light at 254 nm, and outline the spots with a soft pencil. Spray the plate with Ferric chloride–potassium ferricyanide reagent: the RF value (approximately 0.4 to 0.5) of the prin