Identification
Mix a portion of finely powdered Tablets, equivalent to about 1 g of methocarbamol, with 25 mL of water in a separator, and extract with 25 mL of chloroform. Filter the extract, and evaporate to dryness: the residue of methocarbamol so obtained responds to
Identification test
A under
Methocarbamol.
Dissolution, Procedure for a Pooled Sample 711
Medium:
water; 900 mL.
Apparatus 2:
50 rpm.
Time:
45 minutes.
Procedure
Determine the amount of C
11H
15NO
5 dissolved, employing the procedure set forth in the
Assay, making any necessary modifications.
Tolerances
Not less than 75% (Q) of the labeled amount of C11H15NO5 is dissolved in 45 minutes.
Assay
pH 4.5 Buffer solution, Mobile phase, and Chromatographic system
Proceed as directed in the
Assay under
Methocarbamol Injection.
Internal standard solution
Prepare a solution of caffeine in methanol containing about 3 mg per mL.
Standard preparation
Transfer about 100 mg of
USP Methocarbamol RS, accurately weighed, to a 100-mL volumetric flask. Dissolve in about 50 mL of
pH 4.5 Buffer solution and 25 mL of methanol. Add 5.0 mL of
Internal standard solution, dilute with
pH 4.5 Buffer solution to volume, and mix.
Assay preparation
Weigh and powder not less than 10 Tablets. Transfer an accurately weighed portion of the powder, equivalent to 100 mg of methocarbamol, to a 100-mL volumetric flask. Add about 50 mL of pH 4.5 Buffer solution, 25 mL of methanol, and 5.0 mL of Internal standard solution. Shake vigorously for 10 minutes, dilute with pH 4.5 Buffer solution to volume, and mix. Filter, discarding the first 20 mL of the filtrate.
Procedure
Proceed as directed for
Procedure in the
Assay under
Methocarbamol Injection. Calculate the quantity, in mg, of methocarbamol (C
11H
15NO
5) in the portion of Tablets taken by the formula:
100C(RU / RS),
in which
C is the concentration, in mg per mL, of
USP Methocarbamol RS in the
Standard preparation; and
RU and
RS are the peak response ratios of methocarbamol and caffeine obtained from the
Assay preparation and the
Standard preparation, respectively.