Evaluation of stability
study of Ayurvedic formulation Vasavaleha
Dr. Bharti
Ahirwar
SLT Institute of Pharmaceutical Sciences, Guru Ghasidas Vishwavidyalaya, Bilaspur (CG) 495 007
*Corresponding Author E-mail: ah_bharti@yahoo.com
ABSTRACT
Physic-chemical
parameters and residual drug content of vasavaleha (AVB, AVB-1 and AVB-2) was measured at
accelerated temperature. Results showed that no change was noticed in color,
odor ant taste of AVB (prepared vasavaleha) up to storage of 180 days while at the same
temperature after 120 days no changes were observed in odor of AVB-1 and AVB-2
whereas color becomes blackish brown to yellowish brown and taste turns to
bitter. In pH, slight changes were noticed in all the formulations. Moisture content at 0 day of AVB was 3.75%
which reduced after 60 days to 3.74% and after 120 days it was 3.72% while
after 180 days it was found the same 3.72%. Same results were
noticed during the stability study of AVB-1 and AVB-2 except that their %
moisture content was not found constant up to 180 days storage. The percent residual drug content of prepared
(AVB) vasavaleha
was found 94.15% and 92.11%, 92.15% for AVB-1 andAVB-2 after 180 days at 40±1˚ C while 98.05%,
98.21%, 98.08% was estimated after 60 days at 40±1˚ C respectively for AVB, AVB-1 and AVB-2.
KEYWORDS:
INTRODUCTION:
A reference to
various authentic Ayurvedic texts reveals that aspect
of shelf-life has been recognized already and some of the Granths
have actually given guidance regarding factors that make formulations degrade
or become unfit for use, and in specific cases in certain dosage forms have
actually prescribed the period from the date it was compounded within which
such dosage form should be used. Ayurvedic Formulary
of India also has given the time period from the date of manufacture within
which the formulations should be consumed for best results. For example Churna a period of 6 months has been mentioned in AFI
(Anon. 2001).
However,
modern technological advances have made it possible to control and regulate
various aspects of processing during production so as to minimize or even
eliminate ill effect of factors affecting shelf-life mentioned above.
Technological advances also make it possible to control temperature and
humidity in the processing and manufacturing areas hereby building stability of
the formulation during processing and packing.
Exposure to
one or all of the factors mentioned above which are detrimental to stability
can be controlled (Punit et al., 2007; Shah et
al., 2007). Keeping this perspective in mind stability study of different Ayurvedic (prepared and marketed) was carried out on
accelerated temperature study.
MATERIALS AND METHODS:
Physico-chemical parameters
Following
parameters, selected for the stability studies of vasavaleha (Shailesh
2005).
Color
examination:
Five
gram vasavalehas
were taken into watch glasses and placed against white background in white tube
light. They were observed for their color by naked eye.
Odor examination:
Two gram
formulations were smelled individually. The time interval among two
smelling was kept 2 minutes to nullify the effect of previous smelling.
Taste
examination:
A
pinch of each formulation were taken and examined separately for their taste on
taste buds of the tongue. The time interval among each sample was kept about 15
min., so as to make the taste buds available fresh every time.
Moisture
contents of the formulations were determined through KF Titrator.
The titrimetric
solution, known as Karl Fischer Reagents, was used for the titration. 25 µl of
sample when placed into the KF Titrator, sample
reacted with KF reagent, after completion of titration, and apparatus displayed
the percentage of moisture present in that particular sample.
UV spectrum (Robert et al., 2002; Verma 1998):
All the
formulations of vasavaleha
were dissolved in methanol (A.R. grade) in microgram quantities and filtered
and then UV spectrums were scanned at 340 nm.
Preparation
of Standard Curve
Accurately
weighed piperine (100 mg) was taken in 100 ml
volumetric flask and was dissolved in minimum quantity of methanol. The volume
was made up to mark with sufficient quantity of methanol. This gave the
concentration of 200-µg/ ml of stock solution. A set of standard dilutions 2,
4, 6, 8, 10 µg/ ml of drug was prepared by transferring 0.1, 0.2,…,1.0 ml
aliquots to a series of 10 ml volumetric flasks and volumes was made up to 10
ml with methanol and filtered through Whatman No.1 filter paper. Absorbance of
each dilution was measured against blank using Systronic
Double-Beam UV-Visible Spectrometer at 340 nm.
Determination of Residual Drug Content
Stability testing of the prepared and marketed
formulations was performed on keeping the samples at accelerated temperature
conditions. Three formulation batches of vasavaleha (AVB, AVB-1, AVB-2), were taken in amber-colored glass bottles and were kept at
accelerated temperature of 25±1°C, 30±1°C and 40±1°C respectively. The samples were withdrawn at regular intervals of 60, 120
and 180 days to observe any change in percent residual drug contents (Mathew,
1999; Grimm, 1996; Berglund, 1990; Krummen, 1987; Witthaus, 1981; ICH Q1A, 2003). The amount of drug
decomposed and the amount remained (undecomposed
drug) at each time intervals were recorded at a wavelength of 340 nm.
Table 1 Stability studies through
physicochemical parameter of vasavaleha
|
S.No. |
Physicochemical standard
parameter |
Time Duration (after days) |
Accelerated stability
testing at A, B, and C temperature |
||
|
AVB |
AVB-1 |
AVB-2 |
|||
|
1. |
Color |
0 |
Blackish brown |
Blackish brown |
Blackish brown |
|
60 |
NC |
NC |
NC |
||
|
120 |
NC |
NC |
NC |
||
|
180 |
NC |
NC |
NC |
||
|
Inference |
NC |
SC |
SC |
||
|
2. |
Odor |
0 |
Characteristic |
Characteristic |
Characteristic |
|
60 |
NC |
NC |
NC |
||
|
120 |
NC |
NC |
NC |
||
|
180 |
NC |
SC |
SC |
||
|
Inference |
NC |
SC |
SC |
||
|
3. |
Taste |
0 |
Sweetish with warm sensation
|
Sweetish with warm sensation |
Sweetish with warm sensation |
|
60 |
NC |
NC |
NC |
||
|
120 |
NC |
NC |
NC |
||
|
180 |
NC |
SC |
SC |
||
|
Inference |
NC |
SC |
SC |
||
|
4. |
pH value (10% w/v solution) |
0 |
6.18 |
4.13 |
4.11 |
|
60 |
6.20 |
4.19 |
4.15 |
||
|
120 |
6.22 |
4.23 |
4.21 |
||
|
180 |
6.23 |
5.29 |
5.28 |
||
|
Inference |
NC |
SC |
SC |
||
|
5. |
Moisture content % |
0 |
3.75 |
7.43 |
4.66 |
|
60 |
3.74 |
7.31 |
4.60 |
||
|
120 |
3.72 |
7.25 |
4.53 |
||
|
180 |
3.72 |
7.18 |
4.47 |
||
|
Inference |
NC |
SC |
SC |
||
NC = No change, SC = Slight
change, A, B, and C = 25±1˚C, 30±1˚C and 40±1˚C
Figure 1: Standard curve of
Piperine
Table 2 Data for stabilities studies of Vasavaleha
formulations on storage at different temperature
Formulation
Code |
% Residual Drug content on storage at different
temperature and time |
|||||||||||
|
Initial |
60 Days |
120 Days |
180 days |
|||||||||
|
25± 1oC |
30± 1oC |
40± 1oC |
25± 1oC |
30± 1oC |
40± 1oC |
25± 1oC |
30± 1oC |
40± 1oC |
25± 1oC |
30± 1oC |
40± 1oC |
|
|
AVB |
100 |
100 |
100 |
99.63 |
99.54 |
98.05 |
99.55 |
98.42 |
96.63 |
98.35 |
96.47 |
94.15 |
|
AVB 1 |
100 |
100 |
100 |
99.54 |
99.44 |
98.21 |
98.52 |
98.35 |
95.43 |
98.43 |
96.28 |
92.11 |
|
AVB 2 |
100 |
100 |
100 |
99.42 |
99.25 |
98.08 |
97.32 |
96.12 |
93.1 |
96.25 |
95.14 |
92.15 |
RESULT AND DISCUSSION:
It is
important to recognize and be aware of the potential for instability in both
manufactured and extemporaneous products. There is a need to specify storage
control (Winfield et al., 2004). In
the past it was the practice in many pharmaceutical manufacturing companies to
evaluate the stability of pharmaceutical preparations by observing them for a
year or more, corresponding to the normal time that they would remain in stock
and in use. Such a method was time consuming and uneconomical. Accelerated
studies at higher temperatures were also used by most companies (Martin, 2004; Chauhan and Agrawal 1999).
Therefore stability studies were performed at accelerated temperature for up to
180 days for observing changes in physicochemical nature and residual drug
content of all the prepared and marketed formulations. Observation in table 1
revealed that no change was noticed in color, odor ant taste of AVB (prepared vasavaleha) up to
storage of 180 days at accelerated temperature while at the same temperature
after 120 days no changes were observed in odor of AVB-1 and AVB-2 whereas
color becomes blackish brown to yellowish brown and taste turns to bitter. In
case of pH slight changes were noticed in all the formulations at the
accelerated temperature during storage. These changes are very less in
laboratory prepared vasavaleha
than marketed vasavaleha. Moisture content at 0 day of AVB was 3.75%
which reduced after 60 days to 3.74% and after 120 days it was 3.72% while
after 180 days it was found the same 3.72%.
Same results
were noticed during the stability study of AVB-1 and AVB-2 except that their %
moisture content was not found constant up to 180 days storage. Table 2 reveals stabilities studies of Vasavaleha formulations on
storage at different temperature. The percent residual drug
content of prepared (AVB) vasavaleha was found 94.15% and 92.11%, 92.15% for AVB-1
andAVB-2 after 180 days at 40±1˚ C
while 98.05%, 98.21%, 98.08% was estimated after 60 days at 40±1˚ C respectively for
AVB, AVB-1 and AVB-2. These results of
physicochemical parameters and UV spectrum at accelerated stability analysis
reveals that no or very little changes were noticed in these parameters during
the length of time of 180 days, which is indicative of higher stability of the
product and a shelf life of more than 2 years may be assigned to vasavaleha (Chauhan and Agrwal 1999; Shirish et al., 2008).
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Received on 15.10.2012 Accepted
on 20.12.2012
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