Pantoprazole Sodium

• BEYOND-USE DATE: NMT 14 days after the date on which it TEST 1—[NOTE—Protect all solutions from light, and use amwas compounded when stored at controlled cold ber autosampler vials and low-actinic glassware.] temperature Diluent, Mobile phase, System suitability preparation, and • USP REFERENCE STANDARDS 〈11〉 Chromatographic system—Proceed as directed in the Assay. USP Pantoprazole Sodium RS Standard solution—Transfer about 20 mg of USP Pantoprazole Sodium RS, accurately weighed, to a 50-mL volumetric flask, dissolve in 5 to 10 mL of a mixture of acetonitrile and water (1:1), and dilute with Diluent to volume. Further dilute


USP 35
• BEYOND-USE DATE: NMT 14 days after the date on which it TEST 1-[NOTE-Protect all solutions from light, and use amwas compounded when stored at controlled cold ber autosampler vials and low-actinic glassware.] temperature Diluent, Mobile phase, System suitability preparation, and • USP REFERENCE STANDARDS 〈11〉 Chromatographic system-Proceed as directed in the Assay.

USP Pantoprazole Sodium RS
Standard solution-Transfer about 20 mg of USP Pantoprazole Sodium RS, accurately weighed, to a 50-mL volumetric flask, dissolve in 5 to 10 mL of a mixture of acetonitrile and water (1:1), and dilute with Diluent to volume. Further dilute . with Diluent quantitatively, and stepwise if necessary, to obtain Pantoprazole Sodium a solution having a known concentration of about 0.0004 mg per mL.
Test solution-Transfer about 20 mg of Pantoprazole Sodium, accurately weighed, to a 50-mL volumetric flask, dissolve in 5 to 10 mL of a mixture of acetonitrile and water (1:1), dilute with Diluent to volume, and mix.
» Pantoprazole Sodium contains not less than  of monitoring at 290 nm and at 305 nm, and a 4-mm × 12.5-4 Impurities D and F are not fully resolved and should be integrated together.
cm column that contains 5-µm packing L1. The column tem-  (7:3). components based on relative retention times (Table 2): the res-Solution A-Use a filtered and degassed mixture of Ammoolution, R, between pantoprazole related compound E and pannium phosphate buffer and Acetonitrile-methanol mixture toprazole related compounds D and F is not less than 1.5.
(85:15). Chromatograph the Standard solution at 290 nm, and record Solution B-Use Acetonitrile-methanol mixture. the peak responses as directed for Procedure: the tailing factor is not more than 2; and the relative standard deviation for repli-Diluent-Transfer 25 mL of ammonium hydroxide to a suitacate injections is not more than 5.0%.
ble container, and dilute with water to 500 mL. Standard preparation-Transfer about 20 mg of USP Pantosodium in the Standard solution; CU is the concentration, in mg prazole Sodium RS, accurately weighed, to a 50-mL volumetric per mL of Pantoprazole Sodium in the Test solution; F is the flask, dissolve in 5 to 10 mL of a mixture of acetonitrile and response factor of an individual pantoprazole related compound water (1:1), and dilute with Diluent to volume. Further dilute relative to the response of pantoprazole sodium (Table 2); ri is with Diluent quantitatively, and stepwise if necessary, to obtain the peak response of each impurity obtained from the Test solua solution having a known concentration of about 0.06 mg per tion; and rS is the pantoprazole peak response obtained from mL. the Standard solution. The reporting level for impurities is Assay preparation-Transfer about 20 mg of Pantoprazole 0.05%.
Sodium, accurately weighed, to a 50-mL volumetric flask, dissolve in 5 to 10 mL of a mixture of acetonitrile and water (1:1), and dilute with Diluent to volume. Further dilute with

Relative Relative
Diluent quantitatively, and stepwise if necessary, to obtain a so- ponents based on their relative retention times (Table 1): the filtrate with 0.02 N sodium hydroxide to obtain a solution resolution, R, between the pantoprazole related compound A having a known concentration of about 0.2 mg/mL of panand pantoprazole peaks is not less than 10.0. Chromatograph toprazole, based on the label claim. the Standard preparation, and record the peak responses as di-Chromatographic system rected for Procedure: the relative standard deviation for replicate (See Chromatography 〈621〉, System Suitability.) injections is not more than 2.0%.  Time: 120 min with water to a pH of 7.9.

Mode: LC
Determine the amount of pantoprazole dissolved in the Diluent: Mixture of acetonitrile and 0.02 N sodium hydrox-Acid stage using the following procedure. ide (1:1) Sample solution: After 120 min, withdraw an aliquot, Mobile phase: Prepare a mixture of acetonitrile and Solution pass through a suitable filter of 0.45-µm pore size, and A (35:65).
immediately dilute a portion of the filtrate by a factor of Standard solution: Transfer a weighed quantity of USP Pan-2 with 0.5 N sodium hydroxide. Transfer the Tablets to toprazole Sodium RS to a suitable volumetric flask, add 0.02 the vessels containing the Buffer stage medium. N sodium hydroxide to about 60% of the final volume, soni-Diluent: Prepare a mixture of pH 6.8 phosphate buffer cate for 5 min to dissolve, add about 2% of acetonitrile, and and 0.5 N sodium hydroxide (1:1). dilute with 0.02 N sodium hydroxide to volume to obtain a Mobile phase: Acetonitrile, triethylamine, and water solution having a known concentration of about 0.2 mg/mL (40:1:60). Adjust with phosphoric acid to a pH of 7.0 ± of pantoprazole sodium.