In-process quality control parameters of Ayurvedic formulation sitopaladi churna
Bharti Ahirwar*
SLT Institute of Pharmaceutical Sciences, Guru Ghasidas Vishwavidyalaya, Bilaspur (CG)
*Corresponding Author E-mail: ah_bharti@yahoo.com
ABSTRACT:
KEYWORDS:
INTRODUCTION:
The pharmaceutical product development requires a variety of scientific expertise to build-in quality, efficacy and safety, which are the hallmarks of a successful drug product. Understanding of the drug development process and the myriad tasks and milestones that are vital to a comprehensive development plan can only ensure scientific and commercial success of a product in the market. Key steps on the path of product development include pharmaceutical analyses, which include in-process quality control studies are required to determine and assure the identity, potency and purity of ingredients as well as those of the formulated products. Therefore work was concentrated to develop in-process quality control parameters for Ayurvedic formulation sitopaladi churna in present investigation (Ahirwar, 2011; Jain, 2006; Mukharjee 2002; Gattani 2006).
MATERIAL AND METHODS:
Method for preparation of sitopaladi churna
Churna is a fine powder of drug or drugs. All the drugs which, are recorded in Table 1 were cleaned and dried properly. They were then finely powdered separately and sieved through 100 mesh size. Vanslochan was powdered for 6 hours and then all the drugs mixed well and again powdered for 6 hours to uniform mixing and stored (Anon. 1978; Bhaisajratnavali, 2005). Sitopaladi churna was prepared in three batches and coded as CH-1, CH-2 and CH-3.
In-process quality control (Jain et al., 2006, USP 1990, Mukharjee 2002, Amrita et al., 1999, Newton et al., 1995, IP 1996, Pharmacopoeial Standard for Ayurvedic Formulations 1997)
Step 1: All the drugs were powdered and sieved through 100 mesh and subjected to particle size determination (by microscopic method), angle of repose and volatile oil content (by hydrodistillation method).
Step 2: All the powdered drugs mixed well and again powdered for 6 hours for uniform mixing and sieved. Churna so formed was subjected to total ash content, acid insoluble content and water soluble content (by incineration in muffle furnace).
All the observations and results obtained for churna during in-process quality assurance were recorded in Table 2.
Table 1 Ingredients of sitopaladi churna
|
Common |
Botanical name |
Family |
Part used |
Quantity taken |
|
Twak |
Cinnamomum zeylanicum |
Lauraceae |
Bark |
6.1 gm |
|
Ela |
||||
|
Pippali |
Piper longum |
Piperaceae |
Fruit |
24.6 gm |
|
Vanslochan |
Bambusa bambos |
Gramineae |
Earthy concretion |
49.2 gm |
|
Mishri |
--- |
-- |
-- |
100 gm |
Table 2 In-process quality assurance of sitopaladi churna
|
Parameters |
Sitopaladi churna |
||||
|
CH-1 |
CH-2 |
CH-3 |
Mean±SD |
Coefficient of variance |
|
|
Particle Size (µm) |
0.019±0.001 |
0.016±0.110 |
0.013±0.190 |
0.016±0.001 |
0.0519 |
|
Angle of repose (θ˚) |
15.01±1.03 |
13.03±0.18 |
13.01±1.01 |
14.35±1.01 |
1.208 |
|
Volatile oil content (% v/w) |
9.1±1.01 |
12.2±1.13 |
12.1±0.03 |
11.13±1.13 |
1.983 |
|
Total ash (% w/w) |
22.5±1.13 |
21.12±1.14 |
20.2±1.13 |
21.27±1.54 |
2.253 |
|
Acid insoluble ash (% w/w) |
4.1±0.03 |
4.3±0.11 |
4.6±0.19 |
4.33±0.43 |
0.896 |
|
Water soluble ash (% w/w) |
12.6±1.11 |
11.9±1.01 |
12.2±1.09 |
12.23±0.02 |
1.002 |
DISCUSSION:
Comparing with the conventional preparation, herbal products represent a number of unique problems when quality aspects are considered. These are because of the nature of the herbal ingredients present therein, which are complex mixture of different secondary metabolites that can vary considerably depending on environment and genetic factors. These complex positions of quality aspects of herbal drugs are further complicated by the use of combinations of herbal ingredients as are being used in traditional practice (Ahirwar, 2011; Charegaonkar 2005). Standards of any drug relate to the uniformity in quality, which are numerical quantities by which the quality of commodities may be assessed. The information upon which standards may be based is obtained by a study of the genuine drug. While proposing the standards for crude drugs, several aspects are to be considered as pharmacognostical standards (Chouhan, 2001). On the basis of this, to find out a well consistent quality formulation, the standards for formulation development during in-process quality control parameters were developed (Mukharjee 2002, Gattani 2006). The successful formulation from view-points of both physical stability and pharmacologic response also depends on the particle size of the products. Clinically particle size of a drug can affect its release from dosage forms that are administered orally, parenterally, rectally and topically (Martin, 2004). Keeping this perspective in mind particle size was determined of prepared sitopaladi churna. Particle size determination of sitopaladi churna was 0.016±0.001 while angle of repose was estimated as 14.35±1.01. The frictional forces in a loose powder can be measured by the angle of repose θ. This is the maximum angle between the surface of a pile of powder and the horizontal place. If more material is added to the pile, it slides down the sides until the mutual friction of the particles, producing a surface at an angle θ is in equilibrium with the gravitational force. Nelson study shows that angle of repose increased with decreasing particle size. Particles are smaller than 100 mesh to coarse granules resulted in marked increase of the repose angle (Martine 2004). Volatile oil content (%v/w) was estimated as 11.13±1.13 while total ash, acid insoluble and water soluble ash (%w/w) was found to be 21.27±1.54, 4.33±0.43 and 12.23±0.02 respectively. Batch-to-batch coefficient of variance was found 0.0519, 1.208, 1.983, 2.253, 0.896 and 1.002 respectively for particle size, angle of repose, volatile oil content total ash, acid insoluble and water soluble ash. These low limit of variance indicating the reproducibility of the value and hence it may be considered as standard for further reference.
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Received on 27.10.2012 Modified on 12.11.2012
Accepted on 10.12.2012 © AJRC All right reserved
Asian J. Research Chem. 5(12): Dec., 2012; Page 1457-1459