DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF DOLASETRON MESYLATE

Objective: To develop and validate stability indicating HPTLC method for determination of Dolasetron mesylate.Methods: The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F254 using Methanol: Choloroform: Ethyl acetate (7:2:1 v/v/v) as mobile phase followed by densitometric scanning at 280 nm.Results: The chromatographic condition gave a compact spot for Dolasetron mesylate at Rf value of 0.65±0.03. Stress testing was performed in accordance with international conference on harmonization (ICH) Q1A R2 guidelines. Method was validated as per ICH Q2 R1 guidelines. The calibration curve was found to be linear in the concentration range of 100-800 ng/band for Dolasetron mesylate. The limit of detection and quantification was found to2.24 ng/band and 6.79 ng/band, respectively.Conclusion: A new sensitive, simple, and stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for determination of Dolastron mesylate. The proposed method can be used for routine determination of Dolasetron mesylate stability.Â

AN IN VITRO STUDY OF ANTIOXIDANT CAPACITY AND RADICAL SCAVENGING EFFECT OF SPINACIA OLERACEA LEAF EXTRACT

Objective: The study was carried out to evaluate the preliminary phytochemical screening and antioxidant activity of ethanolic extract of Spinacia oleracea (SO).Methods: The leaves of SO were shade dried, and the extract was prepared using solvent ethanol by Soxhlet extraction method. The preliminary phytochemical screening was carried out on the leaf extract of the plant. The total phenolic content and total flavonoids were estimated using Folin- Ciocalteu's and aluminum chloride reagents, respectively. Antioxidant activities were studied using 1,1-diphenyl-2-picrylhydrazyl, nitric oxide, hydrogen radical, lipid peroxidation, and phosphomolybdenum radical scavenging assays.Results: The preliminary phytochemical analysis revealed the presence of bioactive constituents such as phenols, alkaloids, flavonoids, saponins, and glycosides. As SO is a rich source of different bioactive component, it contains a considerable amount of flavonoids and phenols. The different antioxidant assays proved that spinach is one of the best antioxidants with its ability to scavenge different radicals that generate oxidative stress.Conclusion: The observed activity may be associated with bioactive components such as phenols and flavonoids present in the leaf extracts and could have greater importance as nootropic plant in oxidative stress-related degenerative diseases such as Alzheimer and dementia

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING HPTLC METHOD FOR THE ESTIMATION OF PERINDOPRIL AND INDAPAMIDE

Objective: To develop a validated stability indicating HPTLC method for determination Perindopril and Indapamide. Methods: The method was based on the separation of two drugs on plates precoated with silica gel 60 F254 using Dichloromethane: Methanol: Glacial acetic acid in the ratio of 9.5:0.5:0.1 v/v/v as mobile phase followed by scanning in absorbance mode at 215 nm. Results: The optimized chromatographic conditions gave compact spot for Perindopril and Indapamide at Rf value of 0.30 ± 0.02 and 0.60 ± 0.02 respectively. The calibration curve was found to be linear in range of 1000-5000 ng/band and 200-1000 ng/band for perindopril and indapamide respectively. The limit of detection and quantification were found to 164 ng/band and 491 ng/band for Perindopril and 41.41 ng/band and 125.49ng/band for Indapamide. The method has been successfully applied to tablets and was validated according to ICH Harmonized Tripartite guidelines. Conclusion: A new sensitive, simple, rapid and precise high performance thin layer chromatographic (HPTLC) method has been developed and validated for simultaneous determination of Perindopril and Indapamide in pharmaceutical dosage form. The proposed method can be applicable for simultaneous determination of Perindopril and Indapamide in bulk and formulation

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF APIXABAN AS BULK DRUG

Objective: To develop and validate simple, sensitive stability indicating HPTLC (High performance thin layer chromatography) method for apixaban. Methods: The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F254 using toluene: ethyl acetate: methanol (3:6:1 v/v/v) as mobile phase followed by densitometric scanning at 279 nm. Results: The chromatographic condition shows sharp peak of apixaban at Rf value of 0.38±0.03. Stress testing was carried out according to international conference on harmonization (ICH)Q1A (R2) guidelines and the method was validated as per ICH Q2(R1) guidelines. The calibration curve was found to be linear in the concentration range of 100-500 ng/band for apixaban. The limit of detection and quantification was found to be 11.66ng/bandand35.33ng/band, respectively. Conclusion: A new simple, sensitive, stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of apixaban

Evaluation of Hepatoprotective Activity of Hydroalcoholic Extract of Onion Peels Containing Protocatechuic Acid

India is the second largest country for cultivation of onion. 19.90% of onion is cultivated in India. Onion that is Allium cepa family Amaryllidaceae used in daily diet for taste. Onions also have number of medicinal properties, such as hepatoprotection, anticancer, antifungal, antioxidant, antiulcer, anti-agging, anti-inflammatory, anticancer etc.[1-2] The dried scales or peels of onion also have the same medicinal constituents with same activity as raw onions. The onion peels contains flavonoids, such as anthocyanins, flavones (qurcertin and its derivatives), ferulic, Gallic, protocatechuic acids, sulphur, vitamins etc. In the present study determination of protocatechuic acid in onion peels extract has been performed using HPTLC. HPTLC separation was carried out on Merck TLC aluminium sheets precoated with silica gel 60F254 using Toluene: Ethyl acetate: Formic acid (6: 6: 1.2 v/v/v) as mobile phase.[3-11] Quantitative analysis was carried out in the absorbance mode at 258 nm. Hydroalcoholic extract was tested for hepatoprotective activity in wistar rats (either sex) by using CCl4 as hepatotoxicity inducing agent and Silamyrin as standard. Hydroalcoholic extract shows hepatoprotective activity as indicated by decrease in the level of SGOT, SGPT, total protein, billirubin an which hepatotoxicity was induced by CCl4 intraperitonial injection route to animal, from the result it may be concluded that onion peels extract may be used for hepatoprotective activity. Keywords: Onion peel extract, Protocatechuic acid, HPTLC, hepatoprotection

Formulation and Evaluation Transdermal Patch of Hesperidin

The aim of the present study is to formulate and evaluate the transdermal patch of  Hesperidin. In the present study, transdermal patch of  Hesperidin were prepared by using HPMC E 5, Eudragit S 100 as a polymer, Dibutyl phthalate as a plasticizer and glycerin as a lubricant. Nine batches (F1-F9) were prepared by solvent evaporation method using methanol and chloroform in ratio 1:1 as a solvent. The prepared transdermal patches were evaluated on the basis of different parameters like weight, thickness, folding endurance, percent moisture content, drug content , in vitro drug release study. To confirm the optimised batch, the data were computed in design expert software. And it was concluded that the prepared formulation F5 batch showed highest percent of drug release. Keywords: Transdermal drug delivery, Design expert, HPTLC, Hesperidin

Formulation and Evaluation of Chewable Tablets of Pomegranate Peel Extract

Nowadays, dental caries is one of major oral disease caused due to facultatively anaerobic, gram-positive Streptococcus mutans. Pomegranate peel powder extract is known to have activity against Streptococcusmutans. The ethanolic extract of pomegranate peel powder was tested against streptococcus mutans (MTCC 497t). The Minimum inhibitory concentrations was found to be 6.24 mg/ml. Chewable tablet containing 10х MIC of the pomegranate peel powder was tested by cup plate method for its antibacterial activity against Streptococcus mutans. The study concludes that pomegranate peel extract is a  natural antibacterial source can be used in formulating chewable tablet which are better than chemical formulations specially mouth washes as stay-in-mouth time of these chewable tablet  are extended ensuring good antibacterial activity with good organoleptic properties. Keywords: Dental caries, Chewable tablet, Pomegranate peel, Streptococcus mutans

Development and validation of stability indicating high performance thin layer chromatographic method for Budesonide

Objective:- A stability indicating high-performance thin layer chromatographic (HPTLC) method has been developed for Budesonide. Methods:- Chromatographic separation was achieved on aluminium plates pre-coated with silica gel 60 F254 as the stationary phase using ethyl acetate: toluene (7:3)v/v as the mobile phase. The densitometric evaluation was carried out at 246 nm. The developed method of stability indicating was validated as per the ICH Q2 (R1) guidelines. Stress degradation studies like hydrolysis under different pH conditions, photolytic degradation, thermal degradation and oxidative degradation was performed as per ICH Q1A(R2) and Q1B guidelines. Results:- The Rf value of Budesonide was found to be 0.48±0.03. The response in terms of peak area was linear over the concentration range of 500-2500 ng/band with the regression coefficient value greater than 0.99. The LOD and LOQ were 28.04 ng/band and 84.96 ng/band respectively. Conclusion: This method can conveniently be used for quantitative analysis of Budesonide on routine basis

HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE, AND DORAVIRINE

Objective: The objective of this study was to develop and validate an HPTLC method for the simultaneous estimation of Lamivudine, Tenofovir Disoproxil Fumarate, andDoravirine. The method is aimed to provide reliable and efficient quantification of these drugs. Methods: The chromatographic separation of drugs was performed on aluminum plates coated with silica gel 60 F254. Samples were spotted on the plate as a 6 mm wide band using a Linomat applicator and a 100 µl syringe. The mobile phase used was a mixture of ethyl acetate, methanol, and chloroform (07:02:01 % v/v/v). Densitometric scanning at 226 nm was conducted using a Deuterium lamp as the radiation source, and the data were analyzed using winCATS software. The method was validated following the ICH Guideline ICH Q2 (R1). Results:The optimized method lead to the resolution of drugs with the Rf values of Doravirine (0.75±0.02), Tenofovir Disoproxil Fumarate (0.57±0.02), and Lamivudine (0.37±0.02). Doravirine exhibited a linear range of 500-1500 ng/band with a favorable linear equation and regression coefficient of 0.999. Tenofovir Disoproxil Fumarate and Lamivudine showed a linear range of 1500-4500 ng/band, and both compounds displayed a linear relationship with a regression coefficient of 0.997. The method's accuracy was assessed through recovery studies, and the LOD and LOQ were determined for each drug. Conclusion: The optimized HPTLC method was validated in this study, following the ICH Q2 (R1) guidelines, it demonstrates its efficacy for the quantitative analysis of Doravirine, Tenofovir Disoproxil Fumarate, and Lamivudine. The method offers reliable quantification of these compounds in a combined dosage form and can be used for routine analysis in pharmaceuticals

BIOANALYTICAL METHOD FOR TERIFLUNOMIDE ESTIMATION BY HPLC

Objective: The aim of this study was to develop and validate simple and economical HPLC method for estimation of Teriflunomide in human plasma. Method:HPLC method was developed using AgilentEclipse XBD C8 (4.6mm×150mm) as stationary phase and mobile phase used wasammonium acetate buffer: methanol (40: 60 v/v). The detection was carried at wavelength294nm. A simple protein precipitation technique was usedwith acetonitrile as protein precipitating agent andPaliperidone palmitate was chosen as internal standard.Validation was carried out as per USFDA guidelines for bio-analytical method. Results:The linearity range set was 10-60 µg/ml. The value of regression coefficient was found to be 0.9953. Retention time for Teriflunomide was found to be 4.8 mins. The developed method was validated for various parameters like specificity, linearity, accuracy, precision, recovery, and stability. Conclusion: The developed method is simple, rapid and economical for estimation of Teriflunomide in human plasma