Estimation of Sodium Content of Some Commercial Antacid Tablets

Journal of Scientific & Indu strial Research
Vol. 59, October 2000, pp 856-858
Note
Estimation of Sodium Content of
Some Commercial Antacid Tablets
by Flame Photometry
A Manna, A Samanta, D K Pal ,
A Si, S B andopadhyay and P Sures h
Institute of Pharmacy and Techn o logy. Salipur,
C uttack 754 202, Orissa
Received : 03 Juty 2000; accepted: 16 A ugust 2000
Antacids arc marketed widely as over-thecounter (OTC) drugs, which arc generally used for
neu tralisi ng the acid , for relief of heart burn ,
dyspepsia and Jarg·c variety of noiHpccilic
gastro in testinal symptoms. A study on co mposi ti on
of antacid formulatio ns reveal s that a large number
of an tacid for mul ati ons contain alu mi nium
hyd roxide and/or magnesium hydroxide which, in
tu rn , contains some units of sodium ions in it. The
presence of sodi um ions in antacid prepara ti ons is
particularl y contraindicated in patients with known
cardi ac ar:d hypertensive problems. In the present
study, an at tempt is therefore made to study the
con telll of sodi um ions in marketed antacid tablets.
Estimat ion of sodium content was made by Flame
photometry. The study reveals that the formulation
contain s sign ificant concentrati on of sod ium ions ,
which suggests that care must be tal-.en during the
manufactu ring of these hydroxides and certain
specifications are needed by the monograph>
regarding the ~odiu m content of alllacicl
pn.:parations.
The refore, marke ted a ntac id preparations are
likely to contain sodium which may remain in excess
during the preparation of those hydrox ides. E xcess of
sodium ion is detrimental for the cardiac and
hype rten sive patients. Sodium io ns, when present in
large amount in bl ood, cause accumulation of wate r
due to its os moti c capacity. This causes inc rease in
bl ood volume and thereby it increases bl ood
2
pressure . For thi s reaso n, sodium content o f vari ous
marketed antacid tabl ets was dete rmined quantitative ly by Fla me PhotometerH (F igure I ). Flame
photometry ts the eas iest, direct, prec ise and
reproducible method for . determination of sodium
content.
Experimental Procedure
In struments and Reagents
CL 26D F la me Photometer of E li co India
Limited was used. A ll other reagents used were of
ana lyti cal grade .
Method
Preparation of Standard Solution 3 4
254.2 mg of sodium (AR) was d issoived in I 00
ml disti ll ed water to prepare I mg/ml sodium ton
Introduction
Antacid preparations are used com monl y in
typ ical combinations for several reasons. Most of the
antactd preparations gene rally contain aluminium
hydroxide and magnesium hydroxide. Alumini um
hydroxide gel is prepared by mixing sod ium carbonate and alum [AINH.J(SO~h. 12H 20] . Magnesium
hydroxide gd i · prepa red by precipitation us ing
aqueou-; solution of magnesium chloride or sulphate
anJ sodium h ' dro x idei.~.
l
2
3
4
s
Product No.
'
7
8
Fi gure I -Sodium content of some commercial antacid tablet s
857
MANN A eta/,: ESTIM ATION OF SOD IUM CONTE T
Table- ! Product No.
Sodium co ntent of various an tacid tab lets (mg of sod ium per tab let)
Composition
Maga ldrate
Activated si methicone
2
200mg
Magnesium hydroxide gel
150mg
Dried aluminium hydroxide gel
300mg
4
5
6
Alginic acid
7
8
3rd Reading
Mean ±SO
3.04
2.85
3.80
3.23±0.50
21.19
20.28
19.45
20.3 1±0.87
20.91
2 1.95
20.6 1
2 1.1 6±0.70
1.11
0.84
2.1 8
1.38±0.7 1
1.3 9
0. 16
1. 24
0.93 ±0.69
3.2 1
1.18
2.40
1.93 ±0.66
2.49
3.85
3.58
3.3 1±0.72
1. 39
0.50
1.00
0.96 ±0.-+5
70mg
200 mg
Dri ed aluminium hydrox ide ge l
80mg
Sodium bica rbonate
70mg
Magnes ium tris ili cate
20mg
Dri ed alu minium hydroxide ge l
240 mg
Magnesium hyd roxide
l OOmg
Magnesium ca rbon ate
60mg
Activated dimeth ico ne
25mg
Dried aluminium hydroxide ge l
300mg
Magnesi um aluminium si li cate
50mg
Magnesium hydroxide
25mg
Methyl po lysiloxane
lOmg
Dried alumi nium hydroxide gel
225 mg
Mag nes ium hydroxide
200mg
Dimet hi cone
2nd Reading
50mg
Algini c acid
Sodium bicarbonate
3
800mg
1st Reading
50mg
Activated dimcthico ne
250mg
Dried alum in ium hydroxide ge l
500mg
Magnesium tri sili catc
500mg
Dried alumi nium hydroxide gel
250 mg
( I 000 ppm) concentration. 5 ml of thi s so luti o n was
diluted to 50 mi. Different a liqu ots of thi s sol uti o n
were take n in different vo lumetric flasks to prepare
different concentrati o n of sodi um ion .
Preparation of Sample Solution
The suspe ns ion of a well crushed po wde red
antacid tablet was di sso lved in g lass distill ed water
and tran sferred to a 50 ml volumetric flask. The
s uspe nsion was filte red throu g h Whatman fi Ite r
paper. On e ml o f th e filtrate was diluted to 25 ml with
distilled water. Sodium co nte nt was determined fo r
the sampl e by Flame Photomete r. E ight wide ly
ava ilable marketed antacid preparati ons were
sim ilarly investigated .
Results and Discussion
Sodium conten t of variou s antacid tabl ets are
reported in Tabl e I. Results show that the product -5
has lowest quantity of sod ium pe r unit tabl et, product
- 2 and product - 3 have large amount of sodium per
unit dosage form. But majority of sodium is
co ntributed by the sodium bicarbonate IP which is
present a long w ith the aluminium hydro xide ge l a nd
magnesium hydroxide gei.These two formulation s on
the label do not indicate any warning fo r the
hypertensive patients. Therefore, sodi um bicarbonate
shou ld be judic iou s ly c o-admini ste red to ca rdi ac and
hyperten sive pati e nts . P rod uct - 7 and product - I
have cons iderabl e a mount of sodium per unit d ose.
858
J SCI IND RES VOL 59 OCTOBER 2000
Since sodium ion is very much contraindicated
to cardiac and hypertensive patients, consideration
must be given prior to di spen sing an antacid
formulation to such patients. The manufacturing
companies of aluminium hydroxide and magnes ium
hyd roxide gel should restrict the sodium content to
the lowest poss ible extent. Monographs may
prescribe a limit for sodium content of aluminium and
magnesium hydroxide gel.
8017 I RDIT I MON (96-97)199-2000 which has
augmented the research infrastructure for successfu l
completion of thi s work .
References
Remington's The Science and Practice of Pharmacy, 19 th
edn, Vols 1 & 2 (Mack Publishing Co., Easton , Pennsylvania
18042) 1995 , pp 574, 670-671 .
2
Tripath y K D, Essen tials of Medical Pharmacology, 3rd edn
[J aypee Brothers Medical Publishers (P) Ltd , New Delhi]
1994, pp 490.
3
Vogel 's Text Book of Quantitative Chemical Analysis, 15th
edn (ELBS) 1989 , pp 779-784; 8 12-8 13.
4
Beckell A H & Stenl ake J B, Practical Pharmacelllical
Chemistry, 3rd edn, Vol. 2 (C BS Publi shers and Di st ributors ,
Delhi ) 1986, pp 297-30 I.
Acknowledgement
The authors ex press their grat itude to the All
India Council for Tec hni cal Education for the grant of
a financial ass istance to the tune of four lakhs under
the chi ef co-ordinatorship of Dr P Sures h vide Project
Code and Record No. MMEC 6899 (525) vide fil e no.