Development Of HPTLC Method Research Articles

Quality by design (QbD) based development and validation of HPTLC method for simultaneous estimation of ofloxacin and flavoxate hydrochloride: forced degradation study

The purpose of this work was to develop a rapid and reliable HPTLC method for estimating and validating Ofloxacin and Flavoxate by applying QbD techniques. Ofloxacin is used in the treatment of pneumonia and bronchitis while flavoxate in the treatment of overactive bladder. The study utilised a Box–Behnken experimental design utilising response surface methods to examine the impact of migration distance, band length, and chromatographic chamber saturation time on Rf values. Based on the preliminary trials, the Rf values for ofloxacin and flavoxate hydrochloride were observed to be between 0.13 and 0.83 under the chromatographic conditions. The optimized chromatographic conditions included a saturation time of 10 min, a band length of 6mm, a solvent front of 80mm, and a mobile phase composed of methanol: ethyl acetate: Chloroform: Ammonia in a ratio of 3:6:1:0.1 v/v. In compliance with International Conference on Harmonization (ICH) rule Q2 (R1), the enhanced HPTLC method was validated. The study’s findings demonstrate that optimizing the HPTLC method with the number of speculative runs can be accomplished through the effective application of quality by design. For the regular analysis of ofloxacin and flavoxate hydrochloride in combination tablet formulation, the validated HPTLC method worked well.

Validated HPTLC Method for Detection of Kaempferol in <i>Moringa oleifera</i> Leaf Extract and Investigation of its Antidiabetic Potential by <i>In Vitro</i> and <i>In Silico</i> Studies

Background: Exploring traditional treatments offers valuable foundations for the innovation of new pharmaceuticals for the management of diabetes mellitus and its complications. Validation of plant extract by suitable chromatographic techniques is a part of standardization procedures. Moringa oleifera is one such traditionally used plant to be explored. Aim: The study explores the antidiabetic potential of M. oleifera through both in vitro and in silico explorations along with HPTLC method development and validation for estimation of kaempferol in M. oleifera extract. Method: Plant extract was prepared by maceration method using ethanol: water (70:25) and followed by Soxhlet(95% ethanol). Pharmacognostical analysis was conducted. In silico and in vitro antidiabetic and antioxidant studies were conducted, as well as quality control analysis was done using HPTLC method the mobile phase used was toluene: ethyl acetate: formic acid: methanol: (6:3:0.3:1v/v/v/v). Results: HPTLC analysis showed the presence of kaempferol, and the method was validated as per ICH guidelines. According to reports on molecular docking studies, several phytocompounds inhibited when porcine pancreatic α-amylase (PPA) complexed with a carbohydrate inhibitor (PDB ID: 4W93).The hydroalcoholic extract was discovered to have the ability to inhibit α-amylase, with IC50 values of 57.38588±1.92 μg/mL and 32.51564±1.59 μg/mL for standard acarbose, respectively. Conclusion: Overall, this research provides comprehensive data for the estimation of kaempferol in Moringa oleifera by HPTLC and presents valuable evidence on its antidiabetic potential both in vitro and in silico.

Stability Indicating HPTLC Method Development and Validation for Simultaneous Estimation of Spironolactone and Hydrochlorothiazide Bulk and in Tablet Dosage Form

Stability Indicating HPTLC Method Development and Validation for Simultaneous Estimation of Spironolactone and Hydrochlorothiazide Bulk and in Tablet Dosage Form

Stability indicating HPTLC method development and validation for the analysis of novel nitroimidazole antitubercular drug delamanid

Stability indicating HPTLC method development and validation for the analysis of novel nitroimidazole antitubercular drug delamanid

Development and Validation of HPTLC Method for the Estimation of Alectinib in Capsule Dosage Form

Development and Validation of HPTLC Method for the Estimation of Alectinib in Capsule Dosage Form

Stability indicating HPTLC method development and validation of evogliptin in bulk and tablet dosage form by using a QbD approach

This study explains the well-structured development and validation of the HPTLC method and the qualitative evaluation of Evogliptin in both bulk and tablet formulation using the quality by design (QbD) approach. Chromatographic separation was carried out on an aluminium-backed silica gel F254 plate using a mobile phase consisting of ethyl acetate :methanol: triethylamine (6:4:0.1 V/V/V). Densitometry was carried out at a wavelength of 267 nm. The band corresponding to the Evogliptin was obtained at Rf=0.39. The method was found to be linear, with r2=0.9961. The critical analytical attributes (CAAs) for the HPTLC method were identified. The saturation time, band length and solvent front were determined as critical method parameters (CMP) and extensively optimized employing Box-Behnken Design (BBD), with a focus on the retention factor (Rf) value as the CAA. The method described in this study exhibited linearity. The accuracy, precision, linearity, LOD, LOQ and robustness values were within the specified limits. The developed method was validated according to ICH guidelines and the results were found to be within the acceptance criteria. This study effectively demonstrates the value of the QbD approach for creating an incredibly accurate HPTLC method with improved system effectiveness.

Validated Stability Indicating HPTLC Method Development for Rivaroxaban in Tablets

Validated Stability Indicating HPTLC Method Development for Rivaroxaban in Tablets

HPTLC Method Development and Validation for Simultaneous Quantification of Purpurin and Alizarin in Rubia cordifolia L. Roots and their Marketed Preparations

HPTLC Method Development and Validation for Simultaneous Quantification of Purpurin and Alizarin in Rubia cordifolia L. Roots and their Marketed Preparations

Validated HPTLC method development, comparative evaluation and stability study for berberine in herbal preparations

Validated HPTLC method development, comparative evaluation and stability study for berberine in herbal preparations

Development of Simultaneous HPTLC Method and Validation for the Quality Assessment of Ayurvedic Formulation-Ayush Kvatha Churna by Using Marker Compound Rosmarinic Acid, Trans-Cinnamaldehyde and Piperine.

Ayurveda emphasizes the propagation of nature in maintaining health. In the present scenario, we have seen the faith of people in herbal drugs during the Covid 19 outbreak. The raises in the number of peoples have been using herbal drugs to boost immunity against infectious diseases shows the popularity of this ancient system of medicine. The standardization of Ayush Kvatha Churna (AKC), work set out to establish a straightforward, accurate and sensitive HPTLC method for the identification and quantification of marker compounds. The Rosmarinic acid, trans-Cinnamaldehyde and Piperine were used for the estimation of markers in Ayush Kvatha Churna by using HPTLC with a solvent system, consisting of Toluene: Ethyl acetate: Ethyl alcohol: Formic acid (5.6:2.4:2: 0.3v/v/v/v). The Rf value 0.33 for Rosmarinic Acid, 0.69 for Piperine and 0.77 for trans-Cinnamaldehyde was observed and it is exactly complying with the corresponding bands in Ayush Kvatha Churna. The technique has been effectively verified and validated, enabling it to be used for the standardization or quantitative analysis of Rosmarinic acid, trans-Cinnamaldehyde and piperine in Ayush Kvatha Churna.

Quality assessment, HPTLC-DPPH, analytical quality by design based HPTLC method development for estimation of piperine in piper species and marketed formulations

BackgroundQuality assessment of herbs is an essential aspect. In this study HPTLC method is developed by employing the quality based optimization approach with the aid of analytical quality by design tools and the quality assessment of the Piper species. ResultThe Quality assessment was carried out for the piper species which was under the acceptance criteria of Ayurvedic Pharmacopeia of India. Eco-friendly and Quality based HPTLC method was developed and validated for Piperine in Extracts as well as marketed formulation. Further the antioxidant potential was checked by the HPTLC-DPPH (2,2-diphenyl-1-picrylhydrazyl) method. ConclusionQuality assessed extracts and Analytical quality based HPTLC method which was eco-friendly, simple and reliable was developed and validated.

DoE based development and validation of HPTLC method for simultaneous estimation of Curcumin and Naringin in topical gel formulation

DoE based development and validation of HPTLC method for simultaneous estimation of Curcumin and Naringin in topical gel formulation

Development and Validation of HPTLC Method for Simultaneous Estimation of Teneligliptin and Pioglitazone from Their Combined Dosage Form

Development and Validation of HPTLC Method for Simultaneous Estimation of Teneligliptin and Pioglitazone from Their Combined Dosage Form

HPTLC Method Development and quantification of marker compound Gallic acid and Piperine in Ayurvedic Polyherbal formulations: Avipattikar Churna

Ayurvedic medications are becoming more and more well-liked and accepted globally because they are inexpensive and have no negative side effects. There is a chance that original medications will be adulterated with substances that chemically or physically mimic raw pharmaceuticals because of the increasing demand for herbal raw materials for the production of various classical as well as phytoformulation. Avipattikar Churna is an excellent Ayurvedic formulation for treating health issues resulting from an imbalance of Pitta dosha, such as acidity, heartburn, and indigestion. These issues might arise from bad eating habits, a sedentary lifestyle, or a lack of physical activity. Avipattikar Churna is also beneficial for ailments affecting the digestive and excretory systems' ability to operate normally. It counteracts the gastrointestinal tract's acid secretion and encourages the synthesis of digestive enzymes, which facilitate food absorption. Acid dyspepsia, often known as indigestion, is a condition marked by burning and sour vomit, nausea, heartburn (retrosternal burning), and burning in the throat. Avipattikar Churna is beneficial in treating these symptoms. The standardisation process, which can be carried out using a variety of methods and advanced techniques, conforms the identity, quality, and purity of herbal pharmaceuticals. The HPTLC method is superior to other methods since it may be used with herbal medications and is inexpensive, simple to use, and repeatable. For the purpose of evaluating the quality of Avipattikar Churna and identifying any changes made to the drug's composition, an HPTLC method has been devised. The existence and quantity of the marker compound in the sample are confirmed by the overlap of all relevant spectra with the marker. A gramme of Avipattikar Churna (AVC) methanolic extract contained 2.51 mg of piperine and 2.70 mg of gallic acid, the marker compounds.

Stability Indicating HPTLC Method Development and Validation for Acebrophylline in Bulk and its Tablet Dosage Form

A simple, precise, accurate stability-indicating method was developed and validated for Acebrophylline in bulk and tablet dosage form. The chromatographic separation was achieved by using Methanol: Acetonitrile: Acetone: Formic acid (4:4:2:0.1 v/v/v/v) as mobile phase and UV detection at 272nm. The retention factor for Acebrophylline was found to be 0.74±0.10. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation, and robustness as per ICH guidelines. Results were found to be linear in the concentration range of 400-2400ng band -1 with a correlation coefficient of 0.9921. The % assay was found to be 102.4±5. The drug was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis, and thermal degradation. The developed method can be used for the quantification of drug in the dosage form, bulk drug as well as for routine analysis in quality control laboratories.

HPTLC Method Development for Estimation of Vasicine in Herbal Extract and its Marketed Formulations

HPTLC Method Development for Estimation of Vasicine in Herbal Extract and its Marketed Formulations

HPTLC Method Development and Validation for the Simultaneous Estimation of Nortriptyline HCl and Pregabalin in their Combined Dosage Form.

Nortriptyline HCl and pregabalin Tablet is used to treat neuropathic pain as well as mental or mood issues such as sadness, mood, feelings, anxiety and tensions. Very few analytical methods are available for the simultaneous estimation of nortriptyline HCl and pregabalin and no reports has been found for HPTLC method. In the current study, a reliable HPTLC method for the simultaneous measurement of nortriptyline HCl and pregabalin in pure forms and pharmaceutical formulations has been developed with ninhydrine post derivatization of pregabalin. The HPTLC method development was carried using silica gel G60 F254 as stationary phase and acetonitrile: methanol: triethylamine: water: formic acid (7:3:0.3:0.8:0.02v/v/v/v/v) was used as mobile phase with saturation time of 20min. The system was found to give a compact band for nortriptyline HCl (Rf = 0.523 ± 0.008) pregabalin (Rf = 0.279 ± 0.005). The developed method was found to be validated as per ICH Q2 (R1) guideline. The peak of nortriptyline HCl and pregabalin showed good linearity over the concentration range of 50-300ng/band and 350-2250ng/band, respectively, with a correlation coefficient of ˃0.995. The % recoveries of both drugs were found to be in the range of 98.84-101.87%. Statistical analysis proved that the method is selective, precise, robust and accurate for the estimation of nortriptyline HCl and pregabalin.

Development and Validation of HPTLC Method for Estimation of Pimecrolimus in Formulations

Development and Validation of HPTLC Method for Estimation of Pimecrolimus in Formulations

Green HPTLC - Densitometric approach for quantitation of Ruxolitinib in bulk and marketed formulation

Background: This paper describes the development of HPTLC method for the quantitative determination of Ruxolitinib in bulk and tablet dosage form using a systemic approach. A. simple, precise, accurate and specific high performance thin layer chromatographic method has been developed and validated for the Ruxolitinib in bulk and marketed formulation. Methods: The solvent system was 8.0:2.0:0.05 v/v/v of chloroform, methanol, and formic acid. This system was found to give compact spots for Ruxolitinib (Rf value of (0.71±0.02) Densitometric analysis of Ruxolitinib was tested in the absorbance mode at 236nm. Results: The developed method produced linear results with R2 = 0.998 for a range of 100 - 600ng/band. The accuracy of the method was determined at 80, 100, and 120% level. The % recoveries were found to be 100.01%, 99.13%, and 99.82% which are within the limit of 99% to 101%. The LOD and LOQ were found to be 8.19 ng/band and 25.06ng/band indicating the sensitivity of the method. Using the developed method, it was found that intraday and interday RSD values were less than 2%. The method was also found to be robust as indicated by the % RSD values less than 2%. Conclusion: The present method was validated according to the ICH guidelines and it is applied successfully for the determination of Ruxolitinib in tablets.

Principles of White Analytical Chemistry and Design of Experiments to Stability-Indicating Chromatographic Method for Simultaneous Estimation of Thiocolchicoside and Lornoxicam.

A variety of chromatographic methods have been published for the stability evaluation of thiocolchicoside and lornoxicam. Nevertheless, the development of chromatographic methods requires the use of neurotoxic and teratogenic organic solvents that are detrimental to the environment and harmful to human life. Using the principles of design of experiments (DoE), a novel white analytical chemistry-driven stability-indicating high-performance thin layer chromatographic (SI-HPTLC) method has been developed for the concurrent stability study of thiocolchicoside (THC) and lornoxicam (LNX). To protect the environment and human life, the stability-indicating HPTLC method was developed using safe organic solvents. Potential analytical method risk parameters (AMRPs) and analytical method performance attributes (AMPAs) were screened using the fractional factorial design. The response surface analysis and optimization of critical AMRPs and AMPAs was carried out using full factorial design. Navigation of the method operable design region (MODR) was used to develop the SI-HPTLC technique. The developed method was validated as per ICH (International council for harmonization) Q2(R1) guideline. The developed method's greenness was evaluated using AGREE (Analytical Procedure Greenness) tool and ESA (Eco-Scale Assessment). The Blue (B) model was used to assess the proposed method's cost and time efficiency and user-friendlyness. For the stability studies of THC and LNX, the twelve principles of WAC (White Analytical Chemistry) were used to evaluate the published and proposed chromatographic techniques. As compared to previously published chromatographic techniques for studying the stability of THC and LNX, the suggested approach was found to be more affordable, environmentally friendly, and user-friendly. Development of stability-indicating HPTLC method using a novel white analytical chemistry approach and organic solvents with low toxicity potential. Application of the developed method for analysis of the forced degraded sample and fixed-dose combinations of THC and LNX.