Market Formulation Research Articles

Engineering of a novel optimized platform for sublingual delivery with novel characterization tools: in vitro evaluation and in vivo pharmacokinetics study in human

The aim of this work was to develop a novel and more efficient platform for sublingual drug delivery using mosapride citrate (MSP) as a model drug. The engineering of this delivery system had two stages, the first stage was tuning of MSP physicochemical properties by complexation with pure phosphatidylcholine or phosphatidylinositol enriched soybean lecithin to form MSP-phospholipid complex (MSP-PLCP). Changes in physicochemical properties were assessed and the optimum MSP-PLCP formula was then used for formulation into a flushing resistant platform using two mucoadhesive polymers; sodium alginates and sodium carboxymethylcellulose at different concentrations. Design of experiment approach was used to characterize and optimize the formulated flushing resistant platform. The optimized formulation was then used in a comparative pharmacokinetics study with the market formulation in human volunteers. Results showed a marked change in MSP physicochemical properties of MSP-PLCP compared to MSP. Addition of mucoadhesive polymers to flushing resistant platform at an optimum concentration balanced between desired mucoadhesive properties and a reasonable drug release rate. The optimized formulation showed significantly a superior bioavailability in humans when compared to the market sublingual product. Finally, the novel developed sublingual flushing resistant platform offers a very promising and efficient tool to extend the use of sublingual route and widen its applications.

Premnine HCl Estimation in Selected Formulations of ‘Dashmul’ and in Chloroform Extract of Premna integrifolia L. by a Selective, Validated and Developed HPTLC Fingerprint Method

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.

Molecular insight into atypical instability behavior of fixed-dose combination containing amlodipine besylate and losartan potassium

Combination therapy with the use of fixed-dose combinations (FDCs) is evincing increasing interest of prescribers, manufacturers and even regulators, evidently due to the primary benefit of improved patient compliance. However, owing to potential of drug-drug interaction, FDCs require closer scrutiny with respect to their physical and chemical stability. Accordingly, the purpose of the present study was to explore stability behavior of a popular antihypertensive combination of amlodipine besylate (AML) and losartan potassium (LST). Physical mixtures of the two drugs and multiple marketed formulations were stored under accelerated conditions of temperature and humidity (40°C/75% RH) in a stability chamber and samples were withdrawn after 1 and 3 months. The physical changes were observed visibly, while chemical changes were monitored by HPLC employing a method that could separate the two drugs and all other components present. The combination revealed strong physical instability and also chemical degradation of AML in the presence of LST. Interestingly, three isomeric interaction products of AML were formed in the combination, which otherwise were reported in the literature to be generated on exposure of AML free base above its melting point. The same unusual products were even formed when multiple marketed FDCs were stored under accelerated conditions outside their storage packs. However, these were absent when AML alone was stored in the same studied conditions. Therefore, reasons for physical and chemical incompatibility and the mechanism of degradation of AML in the presence of LST were duly explored at the molecular level. The outcomes of the study are expected to help in development of stable FDCs of the two drugs.

Destination Development for Rural Tourism Area in Wanayasa, Puwakarta, West Java, Indonesia

This purpose of this paper is to elaborate the understanding of destination development of rural tourism in Wanayasa, Purwakarta, Jawa Barat. It has a rich potential for the rural tourism prosperity. Then author incorporates destination development through Butler‘s Area Life Cycle. Research was conducted in August 2015 with qualitative approaches i.e. interview and focus group discussion to 120 respondents which comprises representation from several different group. In addition, some of data also produced from secondary sources such as government regulation and official website. Findings show that Wanayasa possessed their ability in developing aspect of internal factors, attractions and accommodation facilities. Apart from that quality, it is obvious that their rural tourism development is lack of destination management and chaotic strategy marketing formulation as a result of disorganized planning processes. With those conditions, it will be tough for them to formulate the true competitive advantage as a basic foundation of their tourism development. This paper illustrates a detailed analysis of the destination‘s strengths and weaknesses, and a more distinctive understanding of what facilitates a destination‘s competitive position.

The Application of Amino Acids in Freeze Dried Protein Formulations.

The development of freeze dried proteins as a market formulation poses a significant challenge to formulation scientists. The choice of a suitable stabilizer to prevent protein degradation during the process is essential and based on sound knowledge of available excipients and their stabilizing properties. Amino acids have been found to exhibit lyo- and cryoprotective effects similar to those of established stabilizers, such as sugars and/or polymers, but offer a greater diversity of chemical structures and physicochemical properties. Their ability to prevent protein aggregation in the liquid and solid states, as well as their beneficial physicochemical properties in frozen and dried state, may render them a new generation of protein stabilizers for freeze drying. The objective of this review article is to provide a summary of research focused on the application of amino acids in freeze dried protein formulations. In addition to the general physical and chemical properties of proteinogenic amino acids, their thermal properties in the frozen and solid states that are relevant to the freeze drying process are discussed. A review of available stability studies illustrating the application of amino acids to protein formulation design and a discussion of currently known mechanisms contributing to solid-state protein stability in amino acid-based systems are also taken into account.

Single and multiple dose pharmacokinetics and pharmacodynamics of omarigliptin, a novel, once-weekly dipeptidyl peptidase-4 inhibitor, in healthy Japanese men.

Aims/IntroductionOmarigliptin is a novel, potent, long‐acting oral dipeptidyl peptidase‐4 inhibitor being developed as a once‐weekly (q.w.) treatment for type 2 diabetes mellitus patients, with 25 mg and 12.5 mg tablets recently being approved as market formulations in Japan.Materials and MethodsThis was a two‐part, double‐blind, randomized, placebo‐controlled study in healthy Japanese men to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of omarigliptin after single dose (5–100 mg) and multiple dose (1–50 mg q.w. for 3 weeks) administration.ResultsOmarigliptin was rapidly absorbed with a time to maximum concentration of 0.5–4 h. The pharmacokinetic profile was biphasic with a long terminal half‐life >100 h. The area under the concentration–time curve from 0 to 168 h, maximum concentration and the concentration at 168 h post‐dose increased dose‐dependently after 3 weeks of once‐weekly dosing for doses ranging 1–50 mg, with accumulation ratios ranging 1.03–1.35 and 0.87–1.36 for the area under the concentration–time curve from 0 to 168 h and maximum concentration, respectively. Plasma dipeptidyl peptidase‐4 inhibition levels 1 week post‐dose increased with dose, ranging 79.2–94.0% after 5–100 mg single dose administration and 51.3–90.2% after 1–50 mg multiple once‐weekly dose administration. Administration with food did not meaningfully alter the pharmacokinetics of omarigliptin. Omarigliptin was generally well tolerated, with no hypoglycemia being reported.ConclusionThe results of the present study in healthy Japanese men showed that omarigliptin was well tolerated and had a pharmacokinetic and dipeptidyl peptidase‐4 inhibition profile that supports once‐weekly dosing in Japanese patients with type 2 diabetes mellitus.

Improving dissolution kinetics of pharmaceuticals by fluidized bed impregnation of active pharmaceutical ingredients

Investigational drugs are increasingly becoming less soluble in aqueous media, thus, presenting real challenges during development. Previous work has successfully demonstrated the manufacturing of pharmaceuticals using fluidized bed (FB) impregnation of APIs onto porous carriers. This study demonstrates the usefulness of FB impregnation in formulating poorly soluble drugs. We show that dissolution of Fenofibrate is greatly improved by FB impregnation onto Neusilin® (Fuji Health Science Inc, Burlington, NJ USA), a synthetic amorphous form of magnesium alumino‐metasilicate. We impregnate Neusilin® for range of loadings and examine Fenofibrate's physical state. Dissolution of impregnated formulations is drug loading dependent and loadings below 40% show great improvement (decrease) in release time compared to physical blend. Release times are further improved by milling. We also examine feasibility of coimpregnating Fenofibrate with additives and observe stability (1.5 years) of the amorphous form of Fenofibrate inside Neusilin®. This stabilization significantly improves Fenofibrate's dissolution kinetics, making our formulation comparable to one of the current market formulations, TriCor® tablets (AbbVie Inc, North Chicago, IL USA). © 2016 American Institute of Chemical Engineers AIChE J, 62: 4201–4214, 2016

Behavior analysis of wind power producer in electricity market

Renewable energy generation plays an important role in exploiting renewable energy towards green economy. The electricity market should be not only reevaluated with the coming of renewable energy, but also modified for maintaining market fairness and better utilization of renewable energy. Based on a Stackelberg game model, this paper puts forward a closed-form analysis on wind power producer’s (WPP’s) behavior in the electricity market involving large scale wind power. The WPP acts as a price-maker in DA market and a deviator in RT balancing market. The analytical expression of WPP’s behavior indicates how a WPP takes an action under various market regulations and statuses, including bidding regulations, deviation settlements, demand elasticity, market capacity, and renewable subsidy. Furthermore, the two-part compound bidding mode is verified and recommended for restraining WPP’s market power when considering ramping constraints of conventional units. The presented models are validated using real-world data based on the IEEE 118-bus test system. Conclusions provide beneficial references for policy formulation of electricity market involving large scale wind power.

Use of Polyvinyl Alcohol as a Solubility-Enhancing Polymer for Poorly Water Soluble Drug Delivery (Part 1).

Polyvinyl alcohol (PVAL) has not been investigated in a binary formulation as a concentration-enhancing polymer owing to its high melting point/high viscosity and poor organic solubility. Due to the unique attributes of the KinetiSol® dispersing (KSD) technology, PVAL has been enabled for this application and it is the aim of this paper to investigate various grades for improvement of the solubility and bioavailability of poorly water soluble active pharmaceutical ingredients. Solid amorphous dispersions were created with the model drug, itraconazole (ITZ), at a selected drug loading of 20%. Polymer grades were chosen with variation in molecular weight and degree of hydroxylation to determine the effects on performance. Differential scanning calorimetry, powder X-ray diffraction, polarized light microscopy, size exclusion chromatography, and dissolution testing were used to characterize the amorphous dispersions. An in vivo pharmacokinetic study in rats was also conducted to compare the selected formulation to current market formulations of ITZ. The 4-88 grade of PVAL was determined to be effective at enhancing solubility and bioavailability of itraconazole.

Stability-Indicating HPTLC Method for Quantitative Estimation of Asenapine Maleate in Pharmaceutical Formulations, Equilibrium Solubility, and ex vivo Diffusion Studies

New high-performance thin layer chromatography (HPTLC) has been successfully developed and validated for quantitative estimation of Asenapine maleate in both marketed tablets and in-house developed formulations (solution, microemulsion, nanoemulsion, and mucoadhesive nanoemulsion) as well as for equilibrium solubility study and ex vivo diffusion study of developed formulation through natural membrane. As suggested by the International Conference on Harmonization, different stress test conditions (alkali, acid, thermal, photolytic, and humidity) were used to degrade Asenapine maleate. The samples produced from this study were utilized to develop a stability indicating HPTLC method. The Asenapine maleate was separated well from degradation products using HPTLC plate; precoated with silica gel G 60 F254 on aluminum sheet as a stationary phase and methanol as a mobile phase. Using densitometric analysis, Asenapine maleate was quantified at 235 nm. The method produced compact band for the drug (Rf = 0.43 + 0.02). The HPTLC method was validated and statistical analysis of the data confirmed the method to be specific, linear, accurate, precise, reproducible, and selective for Asenapine maleate’s analysis. This method was successfully used for assay of Asenapine maleate in both marketed tablets and in-house developed formulations, determining equilibrium solubility in various excipients as well as its ex vivo diffusion study through sheep nasal mucosa from the formulations developed in-house.

Microsponge based drug delivery system for augmented gastroparesis therapy: Formulation development and evaluation

The intention behind the present work was to develop a microsponge based novel dosage form for sustained delivery of domperidone. Quasi-emulsion solvent diffusion method was employed using Eudragit RS-100 with various drug–polymer ratios for the preparation of microsponges. For optimization purposes, several factors which affect microparticles' physical properties were investigated. Characterization techniques followed for the formed microsponges were DSC, FTIR, SEM, XRD and particle size analysis, along with morphology, drug loading and in vitro drug release. It was found that there were no chemical interactions between drugs and polymers used as per DSC and FTIR results. The drug–polymer ratio showed remarkable impact on drug content, encapsulation efficiency and particle size. SEM micrographs revealed that microsponges were spherical in shape with porous surface, and had 104 ± 0.22 µm mean particle size. The microsponges were then loaded in capsules followed by in vitro drug release study; which depicted that microsponges with drug–polymer ratio of 1:2 were more proficient to give extended drug release of 76.38% at the end of 8 h, superior in contrast to conventional marketed formulation Domstal®, which got exhausted incredibly earlier by releasing 82.57% drug at the end of ½ h only. Hence, the developed microsponge based formulation of domperidone would be an expectant, promising substitute to conventional therapy of gastroparesis, emesis and alike gastric ailments.

DEVELOPMENT AND VALIDATION RP-HPLC METHOD FOR ANALYSIS OF FELODIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

The aim of present study was to develop and validate new simple, easy , selective , precise and accurate reverse phase high performance liquid chromatography for the estimation of Felodipine i n bulk and pharmaceutical dosage f orm. The separation was carried on HPLC system consisting C - 18 column (150 x 4.6 mm, 5 μm) at room temperature coupled with a guard column of silic a with flow rate 1 ml/min. The mobile phase used was Acetonitrile: Water in the ratio 70:30. T he drug was detected using UV - Vis detector at the wavelength of 238 nm and the run time was 10 min utes . The retention time was 8.29 minutes. The percentage RSD for precision and accuracy of the method was found to be less than 2 %. The method was validated as per ICH guidelines. The proposed method was fou nd to be accurate, repeatable and consistent. It wa s effectively applied for the analysis of the drug in marketed formul ation and could be used for the regular analysis of formulation containing the Felodipine .

Isolation, characterization and investigation of Cordia dichotoma fruit polysaccharide as a herbal excipient

The objective of the present research work was to isolate, purify and characterize Cordia dichotoma gum and investigate its disintegration property in oral tablets. The isolated gum was tested for physicochemical characteristics such as solubility, pH (1% w/w in water), swelling index, loss on drying, ash value, bulk and tapped density, Carr's index, Hausner's ratio and angle of repose. The Orodispersible tablets of valsartan were prepared by direct compression method and evaluated for average weight (mg), drug content (%), thickness (mm), hardness (kg/cm2), friability (%), wetting time (sec), water absorption ratio (%) and disintegration time (sec). FTIR studies revealed that there was no interaction between drug, gum and other excipients used in the study. The F4 batch with disintegration time 26.34±0.78s and in vitro release 99.64±0.43% was selected as optimized formulation. This formulation was compared with conventional marketed formulation and was found superior. Batch F4 was subjected to stability studies for three months and was tested for its disintegration time, drug contents and dissolution behaviour. Batch F4 was found stable for three months at accelerated temperature.

Preparation and characterization of liquisolid compacts for improved dissolution of telmisartan.

The objective of the present work was to obtain pH independent and improved dissolution profile for a poorly soluble drug, telmisartan using liquisolid compacts. Liquisolid compacts were prepared using Transcutol HP as vehicle, Avicel PH102 as carrier, and Aerosil 200 as a coating material. The formulations were evaluated for drug excipient interactions, change in crystallinity of drug, flow properties, and general quality control tests of tablets using Fourier transform infrared (FTIR) spectroscopy, differential scanning calorimetry (DSC), X-ray diffraction (XRD), angle of repose, and various pharmacopoeial tests. In vitro dissolution studies were performed at three pH conditions (1.2, 4.5 and 7.4). Stability studies were performed at 40°C and 75% RH for three months. The formulation was found to comply with Indian pharmacopoeial limits for tablets. FTIR studies confirmed no interaction between drug and excipients. XRD and DSC studies indicate change/reduction in crystallinity of drug. Dissolution media were selected based on the solubility studies. The optimized formulation showed pH independent release profile with significant improvement (P < 0.005) in dissolution compared to plain drug and conventional marketed formulation. No significant difference was seen in the tablet properties, and drug release profile after storage for 3 months.

Chemometrics assisted quantitative estimation of synthetic and marketed formulations

Promising Four multivariate methods like CLS (Classical least square), ILS (Inverse least square), PCR (Principle component regression) and PLSR (Partial least square regression) were used for the determination of ternary mixture of Clidinium Bromide (CDB), Dicyclomine Hydrochloride (DICY) and Chlordiazepoxide (CDZ) in synthetic and market formulation. Overlapped data was quantitatively resolved by using chemometrics methods, viz CLS, ILS and PLSR methods. Calibrations sets were constructed by means of the absorption data matrix corresponding to the concentration data matrix. A prediction set design of the concentration data corresponding to the CDZ, DICY and CDB mixtures was prearranged statistically to maximize the information content from the spectra and to minimize the error of multivariate calibrations. By applying the respective algorithms for CLS, PLSR, PCR and ILS to the measured spectra of the calibration set, an appropriate model was obtained. This model was selected on the basis of % RSEP and % mean recovery values and the same was applied to the prediction set and tablet formulation. Mean recoveries of the marketed formulation set together with the figures of merit (calibration sensitivity, selectivity, limit of detection, limit of quantification and analytical sensitivity) were estimated. Validation of the proposed methods was successfully assessed for analysis of drugs in the various prepared synthetic mixtures and marketed formulation.

FORMULATION AND EVALUATION OF MUCOADHESIVE GASTRO RETENTIVE TABLET OF LEVAMISOLE BY USING PURIFIED POLYSACCHARIDE ISOLATED FROM TERMINALIA BELLERICA GUM

The present investigation deals with the development of mucoadhesive gastro retensive tablets of levamisole using polysaccharide isolated from Terminalia bellerica gum (TBG). The TBG polysaccharide was tested for acute toxicity and drug–excipient compatibility study. The tablet formulations with TBG were evaluated for physical characteristics like hardness, % friability, % drug content and weight variations. Dissolution study was conducted to characterize release mechanism of the formulation and data are fitted to various kinetic models. The mucoadhesive abilities were studied by different in vitro, Ex vivo and in vivo models. The in vitro release study showed that the optimized formulation exhibited highest correlation (R) value in the case of Korsemeyer–Peppas model and the release mechanism study proved that the formulation showed a combination of diffusion and erosion processes. The mucoadhesive properties of polysaccharide are comparable to synthetic polymer in all Ex vivo, in vitro and in vivo models.  There was a significant difference in the pharmacokinetic parameters (Tmax, Cmax, AUC0-∞, AUC0-t, AUMC, MRT, T1/2, Ka and Kel) of the optimized formulation as compared to standard marketed formulation, which proves the controlled release and mucoadhesive property of the isolated polysaccharide. Keywords- TBG polysaccharide, Scintigraphic, X-Ray study, Korsemeyer–Peppas model

On studying business models in mobile social networks based on two-sided market (TSM)

In contrast to the huge popularity of Mobile Social Network (MSN) services, not sufficient attention has been reserved to the dynamics of revenue streams and business models in MSN. In this paper, we investigate how a two-sided market (TSM) formulation can be used to provide insight for the problem above from the perspective of MSN platform. Intuitively, MSN service platform could be described as a two-sided market, in which the critical feature is indirect value flow (indirect network externality): one/both sides of the market benefit from increasing adoption and/or consumption of the other side. For instance, participants, like consumers and the third service providers (or advertisers), are the "two sides" of MSN platform. In this paper, our contributions are threefold. First, we thoroughly characterize the economic features of MSN as TSM, including mobility, network externalities and herd effect, as well as long tail property. Second, we provide the various revenue streams within the framework of TSM, including advertising, subscription, and transactions, and characterize the basic components of general business model in MSN. Finally, the free plus premium (Freemium) business model in MSN is formally analyzed. Specifically, we quantitatively characterize the relationship of participation levels among free and premium users as well as service providers, and illustrate the mutual enhancement among those participants. And moreover, Freemium is theoretically compared with the traditional business model with no free users (NF model). The numerical results show that, in Freemium, the participation levels of premium users and service providers, as well as the profit of MSN platform always exceed the corresponding terms in NF model.

In-vitro/in-vivo characterization of trans-resveratrol-loaded nanoparticulate drug delivery system for oral administration.

The current studies entail successful formulation of systematically optimized (OPT) nanoparticulate drug delivery system to increase the oral bioavailability using Eudragit RL 100 of trans-resveratrol (t-RVT), and evaluate their in-vitro/in-vivo performance. t-RVT-loaded Eudragit RL 100 nanoparticles (t-RVT NPs) were prepared by nanoprecipitation method. The nanoparticles (NPs) were systematically optimized using 3(2) central composite design and the OPT formulation located using overlay plot. The pharmacokinetic and in-vivo biodistribution of t-RVT NPs were investigated in rats, and various levels of in-vitro/in-vivo correlation (IVIVC) were established. The OPT formulation (mean particle size: 180 nm) indicated marked improvement in drug release profile vis-à-vis pure drug and marketed formulation (MKT). Augmentation in the values of Ka (5.64-fold) and AUC0-24 (7.25-fold) indicated significant enhancement in the rate and extent of bioavailability by the optimized trans-resveratrol-loaded Eudragit RL 100 nanoparticles (OPT-t-RVT NPs) compared with pure drug. Level A of IVIVC was successfully established. OPT-t-RVT NPs showed 4.11-fold rose in the values of t-RVT concentrations in liver. In-situ single pass intestinal perfusion studies construed remarkable enhancement in the absorptivity and permeability parameters of OPT-t-RVT NPs. The results, therefore, insight into the role of solubility enhancement and trounce enterohepatic recirculation for improving the oral bioavailability of t-RVT.

Nanomulsion as a Carrier for Efficient Delivery of Metformin

Metformin (MTF) improves hyperglycemia primarily by suppressing glucose production by the liver. The objective of our investigation was to evaluate nanoemulsion as a promising carrier for MTF for sustained hypoglycemic effect. The drug was incorporated into oil phase of nanoemulsion, which finally improved biopharmaceutical properties achieved when compared with lipid based systems. Pseudo ternary phase diagrams were prepared by aqueous titration method. Formulations were selected at a difference of 5% v/v of oil from the o/w nanoemulsion region of phase diagrams, and then thermodynamic stability and dispersibility tests were performed. The composition of optimized formulation was hydrogenated castor oil (5% v/v), 30% v/v of surfactant (tween 80), co-surfactant (transcutol) and distilled water (65% v/v) as an aqueous phase. The preparation showed maximum drug release (98.70%), optimal globule size (92.25 nm), lowest polydispersity value (0.172), lesser viscosity (22.124 cps) and infinite dilution capability. The antidiabetic activity of optimized MTF nanoemulsion formulation evaluated by blood glucose estimation showed significant hypoglycemic effect which was comparable to that observed with conventional marketed formulation in experimental diabetic rats. Optimized formulation was subjected to stability studies at different temperature and relative humidity and was found to be stable. No significant variations were observed in the formulation over a period of 3 months at accelerated storage conditions.

Development and Validation of HPTLC Method for Simultaneous Estimation of Diosgenin and Quercetin in Fenugreek Seeds (Trigonella foenum-graceum)

A sensitive, fast, and reproducible high performance thin-layer chromatographic method has been developed for simultaneous analysis of diosgenin and quercetin from fenugreek seeds, using TLC aluminium plates precoated with silica gel G60F254. Among the different combinations of mobile phases used, best separation was achieved in Toluene-ethyl acetate-formic acid (5 : 4 : 1, v/v/v). Densitometric scanning of the plates directly at 275nm was used for analysis of quercetin. While as for analysis of diosgenin, plates were scanned at 450nm after spraying with anisaldehyde-sulphuric acid reagent. The retardation factorvalue of diosgenin and quercetin was found to be 0.69 ± 0.02 and 0.57 ± 0.02, respectively. The method was validated for specificity, precision (intraday and interday), accuracy, and robustness. Accuracy of the method was checked by recovery study of three different levels with the average percentage recovery of 99.13 ± 0.26 for diosgenin and 99.63 ± 0.34 for quercetin, respectively. Dried fenugreek seed samples were found to contain diosgenin in the range of 0.113–0.135% (w/w) and quercetin in the range of 0.009–0.012% (w/w). The present method is being reported for the first time and can be used for routine quality control and quantification of these marker compounds in various plant samples, extracts, and market formulations.