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± C while 98.05%, 98.21%, 98.08% was estimated after 60 days at 40± 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. 

Determination of moisture content (Karl Fischer method)

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.

 

Determination of pH

Placed an accurately measure amount 10 gm of vasavaleha in a 100 ml volumetric flask and made up the volume up to 100 ml with distilled water. The solution was sonicated for about 10 minutes. pH was measured with the help of digital pH meter.

 

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± C while 98.05%, 98.21%, 98.08% was estimated after 60 days at 40± 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).

 

REFERENCES:

1.        Berglund M, Bystrom K, Persson B. Screening Chemical and Physical Stability of Drug Substances, Journal of Pharmaceutical and Biomedical Analysis, 1990, 8(8-12): 639-643.

2.        Chauhan SK, Agarwal S. Stability studies of herbal drugs, The Eastern Pharmasist, 1999, 35-36.

3.        Grimm W. Stability Testing of Clinical Samples, Drug Development and Industrial Pharmacy, 1996, 22(9and10): 851-871.

4.        ICH Q1A (R2), Stability Testing of New Drug Substances and Products, 6 February 2003.

5.        Krummen K. Stability Testing During Development, Paperback APV, 1987, 16; 209-225.

6.        Mathews BR. Regulatory aspects of stability testing in Europe. Drug Dev. Ind. Pharm, 1999, 25; 831-856.

7.        Robert M, Silverstein Francis, X Webster. Spectrophotometric Identification of Organic Compounds, Replika Press Pvt. Ltd., Delhi, 6th edition (printed and bound), John Wiley and Sons, Inc. New York, 2002, pp 217-49.

8.        Shah P, Mashru R, Rane Y. Stability testing of Pharmaceuticals- A global perspective, J Pharm Research, 2007, 6 (1): 1-9.

9.        Shailesh Nadkani.  Suvarna Bhasma, Pharma Time, 2005, 37(6); 23.

10.     Shirish S P, Raghunath D P and Mugdha S P. Stability study of a herbal drug, Pharmacologyonline, 2008, 1; 20-23.

11.     Verma SS, Chhabra BS, Ram C, Verma U. The standardization of the seed testing procedure for Isabgol, International Journal of Tropical Agriculture, 1998, 7(3-4): 199-201.

12.     Witthaus G. Drug Stability. Accelerated Storage Tests: Predictive Value, Top. Pharm. Sci., Proc. Int. Congr. Phar, 1981, 275-290.

13.     Anonymous, “The Ayurvedic Pharmacopoeia of India”, Part I, (1st edition), Ministry of Health and Family Welfare, Govt. of India, 2001.

14.    Punit S, Rajshree M and Rane Y. Stability testing of pharmaceuticals – A global perspective, J Pharmaceutical Research, 2007, 6(1); 1-9.

 

 

 

Received on 15.10.2012          Accepted on 20.12.2012        

© Asian Pharma Press All Right Reserved

Asian J. Res. Pharm. Sci. 3(1): Jan.-Mar. 2013; Page 01-04