BAB V PEMBA HA SAN Dalam p e n e l i t i a n i n i digunakan metode pengambilan sam - Pemeriksaan Kadar Sediaan Injeksi Sionokobalamina Bentuk Tunggal Yang Beredar Di Apotik Kotamadya Surabaya Repository - UNAIR REPOSITORY
ADLN-PERPUSTAKAAN UNIVERSITAS AIRLANGGA
B AB V PEMBA HA SAN D a l a m p e n e l i t i a n i n i d i g u n a k a n m e t o d e p e n g a m b i l a n sam
i t i i
p e l P r o p o r t i o n a l a r e a r a n d o m s a m p l i n g d e n g a n m e n g g u n a k a n t & b e l b i l a n g a n r a n d o m . M e t o d a i n i m e r u p a k a n k o m b i n a s i s a m p l i n g d a r i : p r o p o r t i o n a l s a m p l i n g , a r e a s a m p l i n g d a n s i m p l e r a n d o m s a m p l i n g .
S e c a r a g e o g r a f i s l e t a k a p o t i k d i k o t a m a d y a S u r a b a y a t e r s e b a r t i d a k m e r a t a d a l a m a r t i s e t i a p w i l a y a h m e m p u n ya i j u m l a h d a n j a r a k y a n g b e r b e d a - b e d a , s e h i n g g a d i l a k u k a n pem b a g i a n d a e r a h m e n j a d i e m p a t d a e r a h d e n g a n c a r a m e n a r i k g a - r i s h o r i z o n t a l d a n v e r t i k a l , d i ma n a s e b a g a i t i t i k t e n g a h - n y a a d a l a h K a n t o r K o ta m a d y a S u r a b a y a . D i d a p a t k a n d a t a b a h w a d a e r a h A ( 2 9 a p o t i k ) , d a e r a h B ( 2 9 a p o t i k ) , d a e r a h C
( 5 4 a p o t i k ) d a n d a e r a h D ( 6 0 a p o t i k ) . K e t e r a n g a n t e n t a n g d a e r a h A , B , C d a n D d a p a t d i l i h a t p a d a l a m p i r a n 3* U n tu k m e n g e s t i m a s i j u m l a h s a m p e l y a n g d i p e r l u k a n p a d a s u a t u p e n e l i t i a n , u mu mnya d i k a i t k a n d e n g a n p e n e l i t i a n s e b e l u m n y a a t a u d i d a s a r k a n p a d a p e r c o b a a n s e b e l u m n y a . D a l a m h a l i n i p e n e l i t i a n s e b e l u m n y a t i d a k a d a , makn p e r l u d i l a k u k a n p e r c o b a a n p e n d a h u l u a n . B e r d a s a r k a n h a s i l p e r c o b a a n p e n d a h u l u a n t e m y a t a j u m l a h s a m p e l y a n g d i p e r l u k a n a d a
%
l a h 2 d a r i p o p u l a s i . J u m l a h s a m p e l i n i d i p e r k i r a k a n m a s i h t e r l a l u k e c i l , p a d a h a l s e c a r a umum j u m l a h s a m p e l y a n g b e s a r a k a n m e m b e r ik a n h a s i l y a n g l e b i h b a i k . M a k a d a r i i t u d i g u n a k a n e s t i m a s i s a m p e l y a n g l a i n , y a i t u d e n g a n m e n e n tu k a n
31
ADLN-PERPUSTAKAAN UNIVERSITAS AIRLANGGA
32
%
h a r g a D = 0 , 7 , o c = 1 d a n 1 9o. D e n g a n e s t i m a s i d i - d a p a t k a n j u m l a h s a m p e l l e b i h b e s a r , y a i t u 53 s a m p e l ( 22 ) .
U n tu k m e n e n tu k a n j u m l a h a p o t i k y a n g d i j a d i k a n t e m p a t p e n g a m b i l a n s a m p e l p a d a m a s i n g - m a s i n g d a e r a h d a n a g a r p e - n e n t u a n n y a l e b i h p r o p o r t i o n a l , mr- ka d i d a s a r k a n p e r b a n d i n g - a n j u m l a h a p o t i k p a d a m a s i n g - m a s i n g d a e r a h . B e r d a s a r k a n p e r h i t u n g a n , mn ka d a e r a h A = 9 a p o t i k , d a e r a h B = 9 a p o t i k , d a e r a h C = 17 a p o t i k d a n d a e r a h D = 18 a p o t i k .
P e n e n t u a n a p o t i k y a n g d i j a d i k a n t e m p a t p e n g a m b i l a n s a m p e l , d i l a k u k a n s e c a r a r a n d o m d e n g a n m e n g g u n a k a n t a b e l b i l a n g a n r a n d o m .
S e t e l a h d i l a k u k a n p e n g a m b i l a n s a m p e l , t e m y a t a p a d a 5 a p o t i k m e n y e d i a k a n d u a ma ca m s a m p e l , s e h i n g g a j u m l a h s a m p e l m e n j a d i 58 s a m p e l , s e b a b y a n g d im a k s u d s a m p e l d i s i n i a d a l a h s e d i a a n i n j e k s i s i a n o k o b a l a m i n a b e n t u k t u n g g a l y a n g b e r e d a r d i a p o t i k k o ta m a d y a S u r a b a y a d e n g a n k o n s e n t r a s i 1 0 0 0 meg t i a p m l .
D a la m a n a l i s a k u a l i t a t i f d a n k u a n t i t a t i f d i g u n a k a n p e l a r u t a q u a b i d e s t i l a t a p H 4 , 4 , d im a k s u d k a n k a r e n a p e l a r u t t e r s e b u t m e m p u n ya i d e r a j a d k e a s a m a n y a n g s a ma d e n g a n d e r a - j a t k e a s a m a n s a m p e l .
A n a l i s a k u a l i t a t i f d i l a k u k a n s e s u a i d e n g a n m e t o d a d i F a r m a k o p e I n d o n e s i a E d i s i I I I , y a i t u p e r b a n d i n g a n s e r a p a n p a d a k o n s e n t r a s i 25 ppm a n t a r a s e r a p a n p a n j a n g g e l o m b a n g 3 5 9 nm t e r h a d a p 2 7 6 nm d a n 3 5 9 nm t e r h a d a p 548 nm, d e n g m m a k s u d u n tu k m e n g e t a h u i a p a k a h s a m p e l t e r s e b u t m e n g a n d u n g s i a n o k o b a l a m i n a a t a u t i d a k .
ADLN-PERPUSTAKAAN UNIVERSITAS AIRLANGGA
33 D a r i h a s i l a n a l i s a k u a l i t a t i f p a d a s e l u r u h s a m p e l , d i d a p a t k a n d a t a b a h w a :
- D u a s a m p e l d a l a m k e m s s a n a m p u l t i d a k m em en u h i p e r s y a r a t - a n F a r m a k o p e I n d o n e s i a E d i s i I I I , d i ma na p e r b a n d i n g a n s e r a p a n p a d a p a n j a n g g e l o m b a n g 3 5 9 nm t e r h a d a p 276 nm t i d a k m em en u h i p e r s y a r a t a n , s e d a n g k a n p e r b a n d i n g a n s e r a p a n p a d a p a n j a n g g e l o m b a n g 3 5 9 nm t e r h a d a p
548
nm m em en u h i p e r s y a r a t a n . H a l i n i m u n g k in d i s e b a b k a n s a m p e l t e r s e b u t s u d a h d i n y a t a k a n e x p e r i o n d a t e d a n a t a u p e n y i m p a n a n n y a t i d a k b e n a r .
- S e l u r u h s a m p e l d a l a m k e m a s a n v i a l , h a s i l s e r a p a n p a d a n a n j a n g g e l o m b a n g 2 7 6 nm a d a l a h t i g a s a m p a i e m p a t k a l i s e r a p a n p a d a k e m a s a n a m p u l , s e h i n g g a p e r b a n d i n g a n s e r a p a n p a d a p a n j a n g g e l o m b a n g 3 5 9 nm t e r h a d a p 2 7 6 nm t i d a k memenu h i p e r s y a r a t a n d a n p e r b a n d i n g a n s e r a p a n p a d a p a n j a n g g e l o m b a n g 3 5 9 nm t e r h a d a p 548 nm m em en u h i p e r s y a r a t a n ,
H a l i n i m u n g k in d i s e b a b k a n o l e h a d a n y a z a t ta m b a h a n p a d a s e d i a a n t e r s e b u t , m i s a l n y a z a t p r e s e r v a t i f y a n g d n p a t b e r p e n g a r u h p a d a h a s i l s e r a p a n s a m p e l t e r s e b u t ( 25 ) .
A n a l i s a k u a n t i t a t i f d i l a k u k a n d e n g a n m e n g g u n a k a n m e to d a s p e k t r o f o t o m e t r i , y a i t u d e n g a n c a r a m e n g a m a t i s e r a p a n n y a p a d a k o n s e n t r a s i k u r a n g l e b i h 25 ppm p a d a p a n j a n g g e l o m b a n g 3 5 9 n m,
D a r i h a s i l a n a l i s a k u a n t i t a t i f p a d a s e l u r u h s a m p e l , d i d a p a t k a n d a t a b a h w a t i g a s a m p e l t i d a k m em en u h i p e r s y a r a t a n F a r - m a k o p e I n d o n e s i a E d i s i I I I . K e t i g a s a m p e l t e r s e b u t t e r d i r i d a r i :
- d u a s a m p e l y a n g t i d a k m em en u h i p e r s y a r a t a n a n a l i s a k u a l i -
ADLN-PERPUSTAKAAN UNIVERSITAS AIRLANGGA
34 t a t i f t e r n y a t a p a d a a n a l i s a k u a n t i t a t i f j u g a t i d a k m em e- n u h i p e r s y a r a t a n F a r m a k o p e I n d o n e s i a E d i s i J . IT,
- s a t u s a m p e l t i d a k m em en u h i p e r s y a r a t a n , d i ma n a s a m p e l t e r s e b u t p a d a a n a l i s a k u a l i t a t i f m e m e n u h i p e r s y a r a t a n s e d a n g k a n p a d a a n a l i s a k u a n t i t a t i f t i d a k m em en u h i p e r s y a r a ta n . . F a r m a k o p e I n d o n e s i a E d i s i I I I ,
T i d a k m e m e n u h in ya k e t i g a s a m p e l d i a t a s , m u n g k in d i s e b a b - k a n k a r e n a :
- s e d i a a n t e r s e b u t s u d a h d i n y a t a k a n e x p e r i a n d a t e
- p e n g a r u h p e n y i m p a n a n y a n g t i d a k b e n a r
- w a k tu d i p r o d u k s i k a d a r s a m p e l mema n g k u r a n g d a r i p e r s y a r a t a n .
ADLN-PERPUSTAKAAN UNIVERSITAS AIRLANGGA
B AB V I KE S IKP U L A N IA N SA RAN 1• K e s i m p u l a n :
D a r i p e n e l i t i a n y a n g t e l a b d i l a k u k a n d a p a t d i a m b i l k e s i m p u l a n b a h w a : d a r i 58 s a m p e l s e d i a a n i n j e k s i s i a n o k o b a l a m i n a b e n t u k t u n g g a l y a n g b e r e d a r d i a p o t i k k o ta m a d y a S u r a b a y a , m e n u n j u k k a n 55 s a m p e l m em en u h i p e r s y a r a t a n d a n 3 s a m p e l t i d a k m em en u h i p e r s y a r a t a n F a r m a k o p e I n d o n e s i a E d i s i I I I .
2 . S a r a n - s a r a n s D a r i p e n e l i t i a n y a n g t e l a h d i l a k u k a n d a p a t d i s a r a n k a n b a h w a : P e m e r i n t a h h e n d a k n y a m e l a k u k a n p e m a n ta u a n s e c a r a k o n t i n y u t e r h a d a p s e d i a a n i n j e k s i s i a n o k o b a l a m i n a b e n t u k t u n g g a l .
35
ADLN-PERPUSTAKAAN UNIVERSITAS AIRLANGGA
BAB V I I RIU G KAS AN T e l a h d i l a k u k a n a n a l i s a k u a l i t a t i f d a n k u a n t i t a t i f t e r h a d a p s e d i a a n i n j e k s i s i a n o k o b a l a m i n a b e n t u k t u n g g a l y a n g b e r e d a r d i a p o t i k k o ta m a d y a S u r a b a y a ,
P e n g a m b i l a n s a m p e l d i l a k u k a n d e n g a n m e n g g u n a k a n m e to d a
i t t i
P r o p o r t i o n a l a r e a r a n d o m s a m p l i n g d e n g a n m e n g g u n a k a n t a - b e l b i l a n g a n r a n d o m . S e t e l a h d i l a k u k a n p e n g a m b i l a n s a m p e l , d i l a k u k a n a n a l i s a k u a l i t a t i f d a n k u a n t i t a t i f p a d a s e l u r u h s a m p e l .
A n a l i s a k u a l i t a t i f d i l a k u k a n m e n u r u t m e t o d a F a r m a k o p e I n d o n e s i a E d i s i I I I , y a i t u d e n g a n c a r a m e m b a n d in g k a n s e r a g a n s a m p e l d e n g a n k o n s e n t r a s i k u r a n g l e b i h
25 ppm p a d a p a n
j a n g g e l o m b a n g 3 5 9 nm t e r h a d a p 2 7 6 nm d a n 3 5 9 niii t e r h a d a p 5 4 8 n m . D i d a p a t k a n d a t a b a h w a d a r i 58 s a m p e l t e r n y a t a a d a 2 s a m p e l y a n g t i d a k m em en u h i p e r s y a r a t a n F a r m a k o p e I n d o n e s i a E d i s i I I I .
A n a l i s a k u a n t i t a t i f d i l a k u k a n d e n g a n m e t o d a s p e k t r o - f o t o m e t r i , y a i t u d e n g a n c a r a m e n g a m a t i s e r a p a n s a m p e l d e n g a n k o n s e n t r a s i k u r a n g l e b i h ppm p a d a p a n j a n g g e l o m b a n g 3 5 9 nm.
25 D i d a p a t k a n d a t a b a h w a d a r i 58 s a m p e l t e r n y a t a a d a 3 s a m p e l t i d a k m em en u h i p e r s y a r a t a n F a r m a k o p e I n d o n e s i a E d i s i I I I .
D a r i 3 s a m p e l t e r s e b u t t e r d i r i d a r i 2 s a m p e l t i d a k m em en u h i p e r s y a r a t a n a n a l i s a k u a l i t a t i f d a n k u a n t i t a t i f , s e d a n p k a n 1 s a m p e l t i d a k m em en u h i p e r s y a r a t a n a n a l i s a k u a n t i t a t i f n y a s a j a .
36
ADLN-PERPUSTAKAAN UNIVERSITAS AIRLANGGA
BAB V I I RIU G KAS AN T e l a h d i l a k u k a n a n a l i s a k u a l i t a t i f d a n k u a n t i t a t i f t e r h a d a p s e d i a a n i n j e k s i s i a n o k o b a l a m i n a b e n t u k t u n g g a l y a n g b e r e d a r d i a p o t i k k o ta m a d y a S u r a b a y a ,
P e n g a m b i l a n s a m p e l d i l a k u k a n d e n g a n m e n g g u n a k a n m e to d a
i t t i
P r o p o r t i o n a l a r e a r a n d o m s a m p l i n g d e n g a n m e n g g u n a k a n t a - b e l b i l a n g a n r a n d o m . S e t e l a h d i l a k u k a n p e n g a m b i l a n s a m p e l , d i l a k u k a n a n a l i s a k u a l i t a t i f d a n k u a n t i t a t i f p a d a s e l u r u h s a m p e l .
A n a l i s a k u a l i t a t i f d i l a k u k a n m e n u r u t m e t o d a F a r m a k o p e I n d o n e s i a E d i s i I I I , y a i t u d e n g a n c a r a m e m b a n d in g k a n s e r a g a n s a m p e l d e n g a n k o n s e n t r a s i k u r a n g l e b i h
25 ppm p a d a p a n
j a n g g e l o m b a n g 3 5 9 nm t e r h a d a p 2 7 6 nm d a n 3 5 9 niii t e r h a d a p 5 4 8 n m . D i d a p a t k a n d a t a b a h w a d a r i 58 s a m p e l t e r n y a t a a d a 2 s a m p e l y a n g t i d a k m em en u h i p e r s y a r a t a n F a r m a k o p e I n d o n e s i a E d i s i I I I .
A n a l i s a k u a n t i t a t i f d i l a k u k a n d e n g a n m e t o d a s p e k t r o - f o t o m e t r i , y a i t u d e n g a n c a r a m e n g a m a t i s e r a p a n s a m p e l d e n g a n k o n s e n t r a s i k u r a n g l e b i h ppm p a d a p a n j a n g g e l o m b a n g 3 5 9 nm.
25 D i d a p a t k a n d a t a b a h w a d a r i 58 s a m p e l t e r n y a t a a d a 3 s a m p e l t i d a k m em en u h i p e r s y a r a t a n F a r m a k o p e I n d o n e s i a E d i s i I I I .
D a r i 3 s a m p e l t e r s e b u t t e r d i r i d a r i 2 s a m p e l t i d a k m em en u h i p e r s y a r a t a n a n a l i s a k u a l i t a t i f d a n k u a n t i t a t i f , s e d a n p k a n 1 s a m p e l t i d a k m em en u h i p e r s y a r a t a n a n a l i s a k u a n t i t a t i f n y a s a j a .
36
ADLN-PERPUSTAKAAN UNIVERSITAS AIRLANGGA
B AB V I I D A FTA R PU S TAKA.
1 . S y a m s i a h , S i t i . 1 9 7 0 . M a s a l a h S t a b i l i t a s S e d i a a n - s e d i a a n F a r m a s i . B u l l e t i n X S F I J a t i m . 10- 1_ 1_ - 12. p . 160 2 . L i n t n e r , C . J . 1 9 8 0 . S t a b i l i t y o f P h a r m a c e u t i c a l l r o d u c t s i n : R e m i n g t o n ^ P h a r m a c e u t i c a l S c i e n c e s .
16 t h e d . M a ck
P u b l i s h i n g C o m p a n y, E a s t o n P e n n s y l v a n i a , p . 1 4 2 5 3 . L e m b o n g , E . 1 9 7 0 . F a k t o r P e n t i n g B a g i X n d u s t r i F a r m a s i d a l a m U s a h a M e n i n g k a t k a n O b a t - o b a t a n B e r m u tu T i n g g i S e b a g a i A l a t M e m e n a n g k a n P e r s a i n g a n y a n g I ' a k i n I ' e n i n g k a t d i K a s a D a t a n g . B u l l e t i n I S F I J a t i m . 2 . p . 3 3 - 3 4 4 » H em a n . 1 9 7 2 . Q u a l i t y C o n t r o l , S im p o s iu m D r u g C o n t r o l . H . K . F . A r s P r a e p a r a n d i I T B . p . 1 - 35 5 . S u t a r j a d i . 1 9 7 0 . F a r m a k o g n o s i d a n D r u g Q u a l i t y C o n t r o l . B u l l e t i n I S F I J a t i m . 4, . p . 55 6 . B r u e n i n g , C . F . a n d O . L . K l i n e . 1 9 6 1 . R a p i d D e t e r m i n a t i o n o f t h e R e l a t f P u r i t y o f V i t a m i n ( C y a n o c o b a l a m i n a ) i n P h a r m a c e u t i c a l P r o d u c t s . J . P h a r m . S c i . 5 0 * p . 7 3 7 - 53 8 7 . H a s h m i, M . U . H . 1 9 7 2 . A s s a y o f V i t a m i n s i n P h a r m a c e u t i c a l P r e p a r a t i o n . J o h n W i l e y & S o n s . L o n d o n - N e v r y o r k -
S y d n e y - T o r o n t o , p . 1 1 - 1 2 d a n 2 ^ 8 - 276 8 . H a d i , S . 1 9 8 6 . S t a t i s t i k I n f e r e n s i a l - E s t i m a s i . S t a t i s - t i k . J i l i d I I . Y a y a s a n P e n e r b i t a n K a k u l t a s P s i k o l o g i UGK
J o g j a k a r t a , p . 21 9 - 2 5 5
37
ADLN-PERPUSTAKAAN UNIVERSITAS AIRLANGGA
1 0 . D e p a r t e m e n K e s e h a t a n R e p u b l i k I n d o n e s i a , 1 9 7 9 . F a r m a k o p e I n d o n e s i a . E d i a i I I I , p , 18 5 - 186 1 1 . D e p a r t e m e n K e s e h a t a n R e p u b l i k I n d o n e s i a . 1 9 7 2 , F a r m a k o p e I n d o n e s i a . E d i s i I I , p .
38 9 * M a n t r a , I . B . d a n K a s t o . 1 9 8 6 . P e n e n t u a n S a m p e l d a l a m M e t o d e P e n e l i t i a n S u r v a i d e n p a n p e n y u n t i n g M a s r i S i n g a r im b u n d a n S o f f i a n E f f e n d i . L P 3 E S , p . 105 - 130
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