Cyclobenzaprine is used to treat muscle spasms and is usually taken along with rest and physical therapy. It works by helping to relax muscles. The document describes analyzing cyclobenzaprine hydrochloride in tablet samples using HPLC and preparing samples by weighing, extracting, and diluting them. The HPLC method uses an octylsilane column, acetonitrile and potassium phosphate buffer as the eluent, and naphazoline hydrochloride as an internal standard. It also describes production areas for film coated tablets including a coating section with equipment like standard coating pans.

1. Uses
• Cyclobenzaprine is used short-term to treat muscle spasms.
• It is usually used along with rest and physical therapy.
• It works by helping to relax the muscles.
Sampling
• Five multirelax tablets were weighed accurately and powdered. An amount of equivalent to 100 mg of cb
was weighed into 100 ml volumetric flask and extracted with 50ml methanol using an ultrasonic bath for 30
minutes, diluted to volume with the same solvent and filtered. Into 50 ml of the filtered solution suitable
dilutions were made using methanol to prepare tablet solution containing 1 mg/ml for methods 2.5 ml of the
solution was accurately transferred to a 10ml volumetric flask and was diluted to volume with methanol to
prepare tablet solution containing 0.25 mg/ml.
Analysis
1.HPLC
Samples were dissolved in 0.05 N sulfuric acid and diluted with methanol. The cyclobenzaprine
hydrochloride was chromatographed using an octylsilane column and the eluent acetonitrile 0.6% dibasic
potassium phosphate aqueous buffer (pH 3.0) (75:25) at a flow rate of 1.5 ml/min. Naphazoline hydrochloride
was used as an internal standard. The UV detector response at 254 nm was linear for cyclobenzaprine
hydrochloride in the 0.005–0.03 mg/ml range under conditions of the analysis
Chromatogram of Cyclobenzaprine hydrochloride tablet solution containing added Naphazoline
hydrochloride as internal standard.
(I) cyclobenzaprine
(II) naphazoline.
Prof.Dr/ Hesham Salem
Prof.Dr/ Kamal Badr
3-(5H-dibenzo[a,d][7]annulen-5-ylidene)-N,N-
dimethylpropan-1-amine hydrochloride Production area of film coated tablet
• Productions areas should be well lit, particularly where visual on-line controls are carried out.
• Premises should preferably be laid out in such a way as to allow the production to take place in areas connected
in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels.
• Production area contain Coating Section.
Coating section
• Coating section contain Coating Equipment such as(Standard Coating Pan, Perforated Pan, Fluidized Bed/Air
Suspension System).
Standard Coating Pan
Metal pan between about 15 and 200 cm in diameter that is tilted on a benchtop stand. The pan can be rotated
with an electric motor.
A batch of tablets are loaded into the pan which is set to rotate. The rotating motion causes the tablets to tumble
within the pan. Coating solution is applied to the rotating tablet bed by spraying in atomized form which can
produce a faster and more even distribution than simply introducing it as a liquid.
Drying efficiency can easily be achieved by use of a baffled pan and diffuser which allows the distribution of
drying air uniformly over the surface of the tablets.
Standard Coating Pan
Ahmed abdallah
eltayeb
Aya Ragab Khalifa
Fatma elzahraa ali
Abir mahmoud
Fatma mohamed