With the changing pattern of life style most of the diseases are now becoming lifestyle diseases. The world is witnessing an unprecedented growth in the usage of herbal product at national as well as international levels. These have necessitated development of modern and objective standards for evaluating the safety, quality and efficacy of these medicines. The current standards, parameters and protocols available to test the quality of herbal medicines were originally developed for allopathic drugs and can at best authenticate the identity plant materials (may be purity to some extent) not their safety and efficacy. Herbal medicines are natural products and their phytoconstituents depending on time and region, processing and storage . Variations in the collection, processing or storage of an herb could impact its efficacy profile. Since prior knowledge regarding appropriate collection and usage of most medicinal plants exists in tradition, it can be used as a guide to quality standard ization. The parameters of testing the quality of materials (dravya) in traditional medicines, such as rasa (taste), guna (properties), (potency), vipaka (post digestion effects) and karma (action) are very different from the western methods. These traditi onal parameters reflect not only the quality but also efficacy. Having said which, there are no direct written protocols available in traditional medicines either for collection or for testing the action. The methods of testing are lost today need revivifi cation

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Standardi zation of medicinal plant materials

The goal of the study is to establish a simple and precise HPLC method from its commercial formulation for the quantification of Apigenin and Luteolin. The separation of the analytes was performed by Hibar Lichrospher C8 (150 x 4.6mm i.d., 5μ) column with the mobile phase consisting of methanol and 0.5 % trifluroacetic acid (80:20 %, v/v) at 1 ml/min flow rate and 269 nm wavelength detection. The method developed was found to be linear over the concentration ranging from 10 to 110 ng/ml with > 0.99 correlation coefficient (R2) for both Apigenin and Luteolin. The results obtained from the validation studies states that the method developed was found to be simple, precise and accurate in accordance with the ICH guidelines. Through this original research work attempt was therefore made to standardize selected marketed formulations using apigenin and luteolin as an active biological marker for simultaneous quantification through established and validated HPLC techniques.

Development and validation of hplc method for the simultaneous estimation of apigenin and luteolin in commercial formulation

Dashmula are specific ayurvedic combination of ten roots used for various disorders of liver, kidney, uterus. Standardisation of herbals are necessity for efficacy and quality parameter as per WHO guidelines. Therefore, through this original research attempt was made to standardise one of ‘Dashmula’, P. integrifolia and selected batches of marketed formulation using Apigenin and Luteolin as active biological marker for simultaneous quantification and fingerprinting through developed and validated HPTLC techniques. Developed mobile phase Toluene: Ethyl acetate: Formic acid (6:4:0.15) gave Rf (Retention factor) 0.39 and 0.29 for Standard Apigenin and Luteolin respectively at 347 nm iso absorptive wavelength. The ethyl acetate extract of P. integrifolia (PI-ET), ‘Dashmularishtha’: Manufactuer 1; 3 coded batches as DF1, DF2, DF3, Manufacturer 2; 3 coded batches -as BF4, BF5, BF6, ‘Dashmulkadha’: Manufacturer 3; 3 coded batches as KF, KF8, KF9 were found to contain : 12.8% w/w, 0.294 mg/ml%, 0.429 mg/ ml%, 0.314 mg/ml%, 0.077 mg/ml%, 0.071 mg/ml%, 0.145 mg/ml%, 0.176 mg/ml%, 0.242 mg/ml%, 0.098 mg/ml% of Apigenin and 4.7% w/w, 0.542 mg/ml%, 0.365 mg/ml%, 0.569 mg/ml%, 0.343 mg/ml%, 0.311 mg/ml%, 0.607 mg/ ml%, 0.812 mg/ml%, 0.828 mg/ml%, 0.439 mg/ml% of Luteolin respectively. In stem powder of P. integrifolia 19.84 mg/gm% Apigenin and 7.433 mg/gm% Luteolin was calculated. The estimation shows variance in manufacturers and even within batches, but will be quality control parameter. The method was validated for specificity, linearity, accuracy, precision, and robustness. It was found to be linear in range of 40-120 ng/band with regression coefficient 0.9983, 0.9997 for Apigenin and luteolin. Percentage recovery study carried out for extract PI-ET and DF1 with spike of Apigenin and Luteolin at 80, 100 and 120% level, carried out for inter and intraday precision, subjected for one way ANOVA and found F value is below tabulated F(2,6) value 5.14, therefore there is no significance variance of obtained values.

Validation and Development of HPTLC Method for Simultaneous Estimation of Apigenin and Luteolin in Selected Marketed Ayurvedic Formulations of Ã¢ÂÂDashmulaÃ¢ÂÂ and in Ethyl Acetate Extract of Premna integrifolia L.

HPTLC technique developed as validated method for estimation of Premnine HCl in P. integrifolia chloroform extract (PI-AK) and in selected marketed formulations ‘Dashmul arishta’,‘Dashmul kadha’ in 3 × 3 batches as per ICH guidelines. Premnine HCl (Pr-s) was isolated as per literature from P. integrifolia and focused first time as standard bioactive marker for quantification. Developed mobile phase Toluene: Acetone: Diethylamine (7:2:1) for Pr-S gave Rf 0.59 at λ max 283 nm in densitometric scan, focused for specificity, fingerprint and estimation study in PI-AK and selected formulation successively. Linearity assessed in range of 8 to 16 μg /band with regression coefficient of 0.9983, LOD 0.742 μg/Band, LOQ 2.225, also robust for Pr-S. Accuracy for % recovery performed on extract as well on formulation, further subjected for precision study with application one way ANOVA for finding F value, found within limit therefore no significance of variance. A rapid and selective HPTLC method shows good linearity, recovery and high precision, useful method for analysis of Pr-S and as quality control parameter for raw material as well formulation as per foremost need of WHO, FDA and Pharmacopoeia.

https://www.longdom.org/open-access/premnine-hcl-estimation-in-selected-formulations-of-dashmul-and-inchloroform-extract-of-premna-integrifolia-l-by-a-selective-valid-2157-7064-1000352.pdf

Premnine HCl Estimation in Selected Formulations of Ã¢ÂÂDashmulÃ¢ÂÂ and inChloroform Extract of Premna integrifolia L. by a Selective, Validated andDeveloped HPTLC Fingerprint Method

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Validation and Development of HPTLC Method for Simultaneous Estimation of Apigenin and Luteolin in Selected Marketed Ayurvedic Formulations of Ã¢ÂÂDashmulaÃ¢ÂÂ and in Ethyl Acetate Extract of Premna integrifolia L.

Premnine HCl Estimation in Selected Formulations of Ã¢ÂÂDashmulÃ¢ÂÂ and inChloroform Extract of Premna integrifolia L. by a Selective, Validated andDeveloped HPTLC Fingerprint Method