Quality and Potency Analysis of IVY Leaf Extract

Authors’ Contributions 1 conceived the idea, 1,2,3,4 participated in the design of the study and wrote the manuscript, 5-10 designed the project. 11,12 editing of the manuscript. All authors reviewed and approved the final manuscript. Article info. Received: November 13, 2019 Accepted: August 23, 2020 Funding Source: Nil Conflict of Interest: Nil Cite this article: Usman R, Ayaz S, Munir H, Arif A, Shakeel S, Sadia H, Zahoor A, Khanum K, Qamar F, Zainab S, Faridi ZU. Quality and Potency Analysis of IVY Leaf Extract. RADS J Pharm Pharm Sci. 2020; 8(1):58-62. *Address of Correspondence Author: fatimamudassar2009@hotmail.com Background: Hedera helix generally recognized as Ivy or English Ivy and has been employed since a long time in conventional medication in management of respiratory problems. Objective of the study: The current study was conducted with the aim to evaluate Ivy leaf extract to authenticate the quality of extract. Methods: Evaluation was conducted on different physicochemical factors of extract that include physical appearance, organoleptic properties and solubility. Loss on drying, microbial analysis and heavy metal analysis was also carried out to execute the safety of extract. High performance liquid chromatography was executed to evaluate the presence of Hederacoside C in Ivy leaf extract employing phosphoric acid 85 %, acetonitrile, water (2:140:860 v/v/v) as a mobile phase. Results: Extract exhibited greenish brown color, distinctive odor and sweet taste. An Ivy extract was found in agreement of the allowable microbial limit as well as with the heavy metal contents limit. The presence of Hederacoside C in Ivy leaf extract was confirmed by HPLC. Conclusion: The current evaluation reveals conformity with all the analytical procedures. Hence Ivy leaf extract is well standardized formulation at the base line consideration.


I N T R O D U C T I O N
Hedera helix L. belongs to a family Araliaceae and generally recognized as Ivy or English Ivy. The young leaves extract of the plant has been employed since a long time in conventional medication in management of respiratory problems owed to its broncho spasmolytic and expectorant effects [1]. At present a variety of pharmaceutical formulations of Ivy leaf extract including solid, liquid and semisolid dosage forms are accessible for public to cure the ailments [2,3]. There are several clinical trials conducted using Ivy leaves that have verified the effectiveness and quality of such drugs. Due to the investigational and pragmatic proof on its efficiency and safe use, a noteworthy augmentation of its prescribing practices has been observed in several European countries includes Germany [4]. Mass percentage i.e. greater than 80% of plant based expectorants recommended in Germany In 2007, consisted of Ivy leaf extract and accounted to almost two million prescriptions countrywide.
There is a vast variety of chemical constituents that have been isolated from H. helix, including polyacetylenes, triterpene, flavonoids, saponins and various phenolic compounds [5]. A triterpene saponin α-hederin, is known to be accountable for the beneficial consequences of Ivy leaf extract since it possess β2-adrenergic properties [6]. Hederacoside C, an important triterpene saponin, is recognized to be metabolized in the active form and generate the consequences of α-hederin in the body [6,7]. The current investigation was conducted with the plan to evaluate the quality and potency of Ivy leaf extract.

Extract preparation
All the herbal drugs to be utilized in the research were sieved by using mesh #60 and grinded. Every herb was put in extractor; water was used as a solvent in the proportion of 1:10 with herbs. Then finally the decoction was obtained and filtered.

Organoleptic evaluation
Ivy leaf extract was evaluated for its organoleptic properties including color, odour and taste.

Loss on drying
Before testing, Petri dish was kept in the oven at 105°C for 30 minutes and cool the Petri dish by using desiccator and weigh it, the weight was noted as W1.
After accurately weighing transfer about 1.0g of sample into Petri dish and note down the weight as W2. Petri dish was placed with sample into the oven at 105°C for approx 1.5hr. After drying the Petri dish was removed and kept into desiccator. After cooling, the Petri dish was weighed with sample and note down the weigh as W3.

Sample preparation
In 10 volumetric flask, 100 mg of extract was dissolved and diluted using methanol to make up to mark with the same solvent. The solution was then pass through the process of sonification for 30 minutes using ultra sonic bath and filtered by means of a filter having a pore size of 0.45 μm, proceed for HPLC analysis.

Standard solution preparation
In a 10 ml volumetric flask, 10 mg of Hederacoside C standard was taken and dissolved using methanol; make up the volume with methanol. The solution was sonicated in the ultra sonic bath.

Microbial contamination:
Microbiological Examination of Ivy leaf extract was carried out as per the of herbal medicinal products for oral use [8].

Determination of heavy metal contents:
Evaluation of trace elements was carried out by atomic absorption spectrometry flame (FAAS) at the Pakistan Council of Scientific and Industrial Research (PCSIR) Laboratory at Karachi, Pakistan.

R E S U L T S
Ivy leaf extract exhibited greenish brown color, typical odor and sweet taste. A vital practice of flavor masking is executed to remove repulsive drugs from getting contact with the taste buds [9]. ( Table 1). Determination of physicochemical properties plays a significant part in the quality measurement [10].     Entire fungal count NMT 10 2 CFU/g conform Figure 1 represents the structure of Hederacoside C.Loss on drying and assay results are given in Table  2. Figure 2 represents the structure of Hederacoside C. Massive bacteria may be frequently viewed in soil or derived fertilizers [11,12]. Hence there is enhanced probability for the occurrence of microbial pollution in plant based drugs. An Ivy extract was found concord of the permissible microbial confines. Table 3 Plant based drugs are typically accessible as a blend of more than one plant component and its medicinal action relies on its phytochemical components [13].
Precise recognition and quality assurance is an essential prerequisite to make certain reproducible quality of such drugs [14]. Phytochemical evaluation indicates the quality dimension; include preliminary phytochemical analysis, chemoprofiling, and biomarker examination using novel analytical methods. HPLC is a considerable means for the quantitative phytochemical scrutiny of the plant based drugs. In current study Hederacoside C an active biomarker of Ivy leaf was detected and the peak of Hederacoside C complies with standard.

D I S C U S S I O N
The toxic effects of trace metals on human welfare and the atmosphere have fascinated major contemplation in recent years. The heavy metal contents have small excretion rates that may result in unfavorable consequences on human being still at very low amount. Metals for instance copper, manganese, zinc, iron, and chromium are basic nutrients; required for the basic physiological and natural functions of the human being. On the other hand, an increase in their ingestion over definite acceptable confines can turned out to be noxious. There are numerals of healthiness issues linked to excessive uptake of dietary heavy metals [15]. The elements that have been revealed to be noxious are precisely Arsenic (As), mercury (Hg), Cadmium (Cd) and lead (Pb). The concentration of As, Cd, Pb and Hg were examined in Ivy leaf extract and they were not detected in extract ( Table 4).

C O N C L U S I O N S
The current evaluation reveals conformity with all the analytical procedures. The evaluation provides precise and accurate means to develop qualifications for identity, precision and reproducibility of biomarkers in Ivy leaf extract. Hence the extract is well standardized formulation at the base line consideration.