Marketed Tablet Formulation Research Articles

Improved Dissolution Time and Oral Bioavailability of Pioglitazone Using Liquisolid Tablets: Formulation, In Vitro Characterization, and In Vivo Pharmacokinetics in Rabbits.

In the current study, it was intended to prepare liquisolid tablets of pioglitazone HCl to improve the bioavailability and dissolution time of the drug, as it has low solubility in water. Mathematical formulas were adopted, and the quantities of the carrier (MCC), coating material (colloidal silicon dioxides), and nonvolatile liquid vehicle (Tween 80) were taken. Various ratios of the drug to liquid and carrier to coating had been used in the formulation of liquisolid compacts. The evaluation of the formulated liquisolid compacts was done by performing FTIR, DSC, XRD, and SEM studies. Postcompression parameters, dissolution, stability, and bioavailability were accessed for the optimized formulation. FTIR and DSC studies showed the compatibility of the drugs and excipients. XRD revealed the transition to the amorphous state. It was found that the properties of the newly manufactured liquisolid tablets were within the parameters of what is considered acceptable. The optimized formulation of LST10 showed 99.87 ± 0.19% (p < 0.05) pioglitazone released within 60 min of dissolution. Dissolution data treatments (Q 15, IDR, RDR, %DE, MDT, f 1, and f 2) resulted in better drug release than other drugs studied and marketed tablet formulations. The optimized formulation produced had been proven stable when it was subjected to accelerated stability testing. This suggested that the bioavailability of pioglitazone was enhanced, as indicated by the substantial increase in AUC0-t (3.06-fold) and C max (4.18-fold). According to the findings, the selected combination and method significantly increased the dissolution time and bioavailability of pioglitazone. Moreover, this developed method can be used for other drugs with low water solubility.

QbD-driven development of phospholipid-embedded lipidic nanocarriers of raloxifene: extensive in vitro and in vivo evaluation studies.

Raloxifene (RLX) is popularly indicated in treatment of osteoporosis and prevention of breast cancer. Owing to its poor aqueous solubility, high pre-systemic metabolism, intestinal glucuronidation, and P-glycoprotein (P-gp) efflux, however, it demonstrates low (< 2%) and inconsistent oral bioavailability. The current work, Quality by Design (QbD)-driven development of phospholipid-embedded nanostructured lipidic carriers (NLCs) of RLX, accordingly, was undertaken to potentiate its lymphatic uptake, augment oral bioavailability, and possibly reduce drug dosage. Factor screening and failure mode effect analysis (FMEA) studies were performed to delineate high-risk factors using solid lipid (glyceryl monostearate), liquid lipid (vitamin E), and surfactant (Tween 80). Response surface optimization studies were performed employing the Box-Behnken design. Mathematical and graphical methods were adopted to embark upon the selection of optimized NLCs with various critical quality attributes (CQAs) of mean particle size as 186nm, zeta potential of - 23.6mV, entrapment efficiency of 80.09%, and cumulative drug release at 12h of 83.87%. The DSC and FTIR studies, conducted on optimized NLCs, indicated successful entrapment of drug into the lipid matrix. In vitro drug release studies demonstrated Fickian diffusion mechanism. In vivo pharmacokinetic studies in rats construed significant improvement in AUC0-72h (4.48-folds) and in Cmax (5.11-folds), unequivocally indicating markedly superior (p < 0.001) oral bioavailability of RLX-NLCs vis-à-vis marketed tablet formulation. Subsequently, level "A" in vitro/in vivo correlation (IVIVC) was also successfully attempted between the percentages of in vitro drug dissolved and of in vivo drug absorbed at the matching time points. In vitro cytotoxicity and cellular uptake studies also corroborated higher efficacy and successful localization of coumarin-6-loaded NLCs into MG-63 cells through microfluidic channels.

A sensitive, precise, accurate, and economic planar chromatographic method developed and validated for quantification of Desidustat as per guideline

AbstractAnemia with chronic kidney disease treating newer hope is recently approved Desidustat. By following International Conference on Harmonization Quality guideline Q2 (R1), an economic high‐performance thin‐layer chromatography method has been developed for the estimation of Desidustat. Pre‐coated silica gel 60 F254 plates as stationary phase along with mobile phase toluene:methanol:glacial acetic acid (7.5:2.5:0.3 v/v/v), and 230 nm detection wavelength was selected as optimized. Developed method was found linear in quantity per band range of 100 ng/band to 600 ng/band for Desidustat with 0.9979 regression coefficient. Standard spiking method showed method accuracy with a mean percentage recovery of 99.21%–101.63%. Limit of detection and limit of quantitation were found to be 3.94 and 11.94 ng/band, respectively. The method was found to be linear, precise, accurate, robust, rugged, selective, sensitive, and specific for the quantification of Desidustat in bulk and tablet dosage form and successfully can be applied for the qualitative and quantitative determination of Desidustat in bulk and marketed tablet formulation.

Nano-suspension loaded mucoadhesive mouth dissolving film of meclizine hydrochloride

Meclizine Hydrochloride belongs to class H1 antagonist, antiemetic and anti-vertigo in nature, it is a Biopharmaceutical classification system (BCS) class II drug and is practically insoluble in water. The bottom-up approach was used in the formulation of nanosuspension in which methanol and millipore water was used as solvent and anti-solvent respectively, the stabilizers used for preparation were Polyvinylpyrrolidone K30 (PVP K30) and Hydroxypropyl Methylcellulose E15 (HPMC E15) which were found to be compatible with the formulation after Fourier Transform Infrared (FTIR) and Differential scanning calorimeter (DSC) studies. Mouth dissolving films were formulated by solvent casting method using glycerine lubricated petri dish and were kept for heating in a hot air oven at 45°C overnight. Characterization of nanosuspension-loaded mucoadhesive mouth dissolving films was done by evaluating various characteristics, the highest drug content was found to be 92.43±0.49% in Mouth dissolving film (MDF) 2. In-vitro drug release studies indicate that nanosuspension-loaded mucoadhesive mouth-dissolving film has a rapid drug release rate as compared to plain drug-loaded mouth-dissolving films and marketed tablet formulation.

Advancing posaconazole quantification analysis with a new reverse-phase HPLC method in its bulk and marketed dosage form.

Introduction: Posaconazole is a widely used antifungal drug, and its accurate quantification is essential for quality control and assessment of its pharmaceutical products. This study aimed to develop and validate a reverse-phase high-performance liquid chromatography (HPLC) analytical method for quantifying Posaconazole in bulk and dosage form. Methods: The HPLC method was developed and validated based on International Conference on Harmonisation (ICH) guidelines. The developed method was then applied to quantify Posaconazole in a marketed tablet formulation. The method's specificity, linearity, precision, accuracy, robustness, and stability were evaluated. Results: The developed HPLC method showed good linearity over a 2-20 μg/mL concentration range. The percentage recovery of Posaconazole from the bulk and marketed formulations was found to be 99.01% and 99.05%, respectively. The intra-day and inter-day precisions were less than 1%, and the method was stable under different conditions. The HPLC method was successfully applied to quantify Posaconazole in the marketed formulation. Conclusion: The developed and validated HPLC method is reliable and efficient for analyzing Posaconazole in bulk and dosage forms. The method's accuracy, precision, specificity, linearity, robustness, and stability demonstrate its effectiveness. The method can be used for the quality control and assessment of Posaconazole-containing pharmaceutical products.

Advancing posaconazole quantification analysis with a new reverse-phase HPLC method in its bulk and marketed dosage form

Introduction: Posaconazole is a widely used antifungal drug, and its accurate quantification is essential for quality control and assessment of its pharmaceutical products. This study aimed to develop and validate a reverse-phase high-performance liquid chromatography (HPLC) analytical method for quantifying Posaconazole in bulk and dosage form. Methods: The HPLC method was developed and validated based on International Conference on Harmonisation (ICH) guidelines. The developed method was then applied to quantify Posaconazole in a marketed tablet formulation. The method's specificity, linearity, precision, accuracy, robustness, and stability were evaluated. Results: The developed HPLC method showed good linearity over a 2-20 μg/mL concentration range. The percentage recovery of Posaconazole from the bulk and marketed formulations was found to be 99.01% and 99.05%, respectively. The intra-day and inter-day precisions were less than 1%, and the method was stable under different conditions. The HPLC method was successfully applied to quantify Posaconazole in the marketed formulation. Conclusion: The developed and validated HPLC method is reliable and efficient for analyzing Posaconazole in bulk and dosage forms. The method's accuracy, precision, specificity, linearity, robustness, and stability demonstrate its effectiveness. The method can be used for the quality control and assessment of Posaconazole-containing pharmaceutical products.

Validated RP-HPLC Method for Simultaneous Estimation of Perphenazine and Amitriptyline in Bulk and Tablet Dosage form

A new, simple, precise, rapid, selective and stability reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous quantification of Perphenazine and Amitriptyline in pure form and its pharmaceutical dosage form. The method is based on Phenomenex Gemini C18 (4.6×250mm) 5µ column. The separation is achieved using isocratic elution by Methanol: TEA Buffer in the ratio of 65:35% v/v, pumped at flow rate 1.0mL/min and UV detection at 230nm. The column is maintained at 40°C throughout the analysis. The total run time is about 6min. The method is validated for specificity, accuracy, precision and linearity, robustness and ruggedness, system suitability, limit of detection and limit of quantitation as per International conference of harmonization (ICH) Guidelines. The method is accurate and linear for quantification of Perphenazine, Amitriptyline between 10 - 50µg/mL and 20 - 100µg/mL respectively. Further, satisfactory results are also established in terms of mean percent- age recovery (100.37% for Perphenazine and 100.34% for Amitriptyline, intra-day and inter-day precision (&lt;2%) and robustness. The advantages of this method are good resolution with sharper peaks and sufficient precision. The results indicate that the method is suitable for the routine quality control testing of marketed tablet formulations.

Design and optimization of liquisolid compact based vaginal sustained release tablet of antifungal agent for vaginal candidiasis

Antifungal therapy is causing an alarming drug resistance problem during the treatment of Vaginal Candidiasis and also many of the antifungal vaginal marketed formulations have reported major side-effect of the irritation. Hence the quest for natural therapy is currently booming. Lawsone is having poor aqueous solubility and its antifungal activity is therefore hindered. Therefore, the present research work aimed to formulate the liquisolid compact based vaginal tablet of Lawsone to improve its solubility and dissolution rate. The tablet was optimized by 32 full factorial design. The independent factors selected were carrier (Neusilin US2): coating material (Aerosil 200) ratio (R) and concentration of the mucoadhesive polymer (HPMC K4M) while the dependent factors studied were in vitro release (6 h and 12 h) and mucoadhesive strength. The drug was dispersed in nonvolatile solvent (polyethylene glycol 400) to prepare the liquid medicament that was further used for liquisolid compact. The FTIR, DSC and XRD studies revealed no incompatibility between Lawsone and the excipients of the tablet and suggested that the drug was dispersed completely into the liquid medication and therefore transformed from crystalline to amorphous state. In vitro release study suggested sustained release with enhanced dissolution of optimized liquisolid compact tablet LT7 (94.92%) than the plain tablet (61.16%). The in vitro antifungal activity against C. albicans, C. glabrata and C. krusei for liquisolid tablet and the marketed tablet formulation showed insignificant difference.

Development and Validation for the Simultaneous Estimation of Rilpivirine and Dolutegravir in Bulk and Pharmaceutical Dosage Forms by RP-HPLC Method

Background: A simple new novel, accurate, robust and precise RP-HPLC method was developed and validated for the simultaneous quantification of Rilpivirine and Dolutegravir in bulk and marketed tablet formulations. Methods: The method development was carried out by using INERTSIL ODS column (250×4.6mm, 5µm), by isocratic approach using a mixture of Phosphate Buffer (pH 6.8): Acetonitrile in the ratio of (35: 65) as mobile phase. The flow rate was 1.0 ml/min, 259 nm as detection wavelength. Results: The retention time of 3.285 min was observed for Dolutegravir and 4.635 min for Rilpivirine. Dolutegravir percentage purity was 99.97% and 100.63% for Rilpivirine. The system suitability parameters such as theoretical plate and tailing factor for Dolutegravir and Rilpivirine was observed in the range of 3209, 1.13 and 5210, 1.11and was found to be within the limit. The linear was observed in the concentration ranges of 50µg – 250µg for Dolutegravir and 30µg - 150µg for Rilpivirine and correlation coefficient (r2) value for Dolutegravir was 0.999 and 0.999 for Rilpivirine. The percentage RSD for repeatability was observed to be within the acceptance limit 0.1 and 0.7. The percentage RSD for intermediate precision was 0.4 and 0.8. The precision study was precise, robust, and repeatable. The LOD values were 3 and 3.02 and LOQ values were 9.98 and 10.01. Conclusion: Hence the optimized RP-HPLC method can be used for simultaneous quantification and concurrent analysis of Dolutegravir and Rilpivirine in API and combined dosage formulations.

Development of simple, precise UV spectroscopic methods for the estimation of Lamotrigine in bulk and marketed tablet

Two Simple and precise UV spectroscopic methods were developed for the estimation of lamotrigine in bulk and marketed tablets. The methods developed by using two solvent systems viz., Acetonitrile: Distilled water (1:1) and Methanol: 0.1N HCl (3:1) were validated as per ICH guidelines. The two proposed solvent systems validated for linearity, accuracy, precision, robustness, ruggedness and solution stability. The percent recovery in the marketed tablet formulation was found to be good agreement with the label claim. The methods validated statistically and the results suggest these methods can employed for the routine analysis of lamotrigine in bulk and marketed tablet formulations.

A Simple Non-Linear Kinetic Model to Evaluate Stability of a Pressure Sensitive Drug

Candesartan cilexetil is challenging to formulate due to pressure induced chemical degradation. We report a statistical model based on stability data set of a marketed tablet formulation. Impurity increase over time was fitted to a reparametrized second-order kinetic model. Both kinetic model parameters have mechanistic interpretation: parameter a relates to the overall extent of pressure induced instability (the ceiling impurity level) and parameter b relates to the initial rate of degradation (how fast the ceiling is reached). A hierarchical model was then used to quantify sensitivity to tableting pressure and humidity-corrected Arrhenius equation quantified sensitivity to temperature and moisture. An overall model, based on four predictors and five estimated parameters allowed fitting of the entire stability dataset (694 stability data points) with good accuracy. Learnings allowed development of a stable formulation (soft tableting, increasing tablet size/shape and reducing moisture) and resulted in a confident stress stability test to evaluate any future product changes in a timely manner.

Characterization of Oxidative Degradation Product of Canagliflozin by LC-MS/MS

Prior knowledge of chemical stability of drugs directs path for right selection of dosage form, excipients, storage conditions and packaging material. Literature survey revealed that, there are analytical methods reported for quantification and stability indication of Canagliflozin in bulk and formulation. But there is not much information available about the degradation products generated under different stability conditions. With this background, characterization of oxidative degradation product of Canagliflozin was successfully carried out by Liquid Chromatography-Mass Spectrometry (LC-MS/MS) studies. Degradation product was generated by forced degradation, according to International Conference on Harmonization (ICH) guidelines. Degradation product was separated from Canagliflozin by validated reverse phase (RP)-HPLC method using C18 column and Acetonitrile: Water pH 3.0 adjusted with 0.1% formic acid (70: 30, v/v) as mobile phase at a flow rate of 1mL/min. The developed RP-HPLC method was validated for different parameters as per ICH guidelines. The method was found to be linear in a range of 25-225 μg/mL. The developed method was found to be specific, accurate, precise, sensitive and robust. The marketed tablet formulation was analyzed by the developed method and the percent drug content was found to be 100.09 ± 1.96 % w/w. Separated degradation product was characterized by LC-MS/MS studies. From LC-MS/MS data probable structure of the degradation product was interpreted and the mechanism of degradation was proposed. The probable structure of degradation product was proposed as2-(4-Fluorophenyl)-5-({2-methyl-5-[3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]phenyl}methyl) thiophene-1-one. The mechanism of degradation was proposed by S-oxidation of thiophene ring to form thiophene oxide. This information will help synthetic chemists to design a synthesis scheme for the oxidative degradation product, which can be used as a reference standard for impurity profiling. It is also suggested to protect CN from oxidative conditions for improved stability.

Influence of Newly Synthesized Superdisintegrant on Dissolution Rate Enhancement of Carbamazepine using Liquisolid Compact Technique

The purpose of this study was to manufacture liquisolid compact of high dose poorly water-insoluble drug, Carbamazepine (CBZ) by using novel superdisintegrant for the purpose of fast disintegration and improved its dissolution rate. The solubility of CBZ was analyzed in various non-volatile solvents in order to find the vehicle with the maximum solubility. The dissolving profile of liquisolid compacts was compared to a marketed tablet formulation's dissolution profile. CBZ was found to be much more soluble in polyethylene glycol 200 than in the other solvents. Crosspovidone-containing formulations showed no disintegration, but all other formulations disintegrated after 91.2 seconds. A Starch Glutamate-Croscarmellose Sodium combination has a disintegration time of 42.5 seconds. The optimized batch NSC1 including Starch Glutamate-Croscarmellose Sodium had 94.81 % greater drug release compared to the marketed formulation. This investigation found that the novel superdisintegrant had the fastest disintegration and the highest drug release compared to other disintegrants.

Invitro and in-vivo evaluation of optimized sustain release nanoparticulate tablet of vildagliptin

The objective of the present investigation was to evaluate pharmacodynamics and pharmacokinetic parameters of optimized nanoparticulate sustain release tablet of Vildagliptin prepared by using Anti-solvent method containing polymer HPMC K15M and Sodium Alginate in a ratio of 1:0.75. The optimized nanoparticulate tablet test formulation demonstrated favorable in-vitro drug release characteristics. The nanoparticulate formulation was orally administered to rat and blood samples were used to determine pharmacokinetic parameters, which were compared with pharmacokinetic parameters of the marketed tablet formulation. The relative bioavailability of Nanoparticulate tablet was found to be increased about 1.2 times in comparison to that of the marketed tablet. The results for invitro drug release and in vivo antidiabetic activity for 24 hours were also found very significant. As per results obtained from in vitro and in vivo studies, nanoparticulate tablet of Vildagliptin may prove to be a potential contender for secure and efficient sustained drug release over an absolute phase of time which can decrease dosing frequency.

QbD Approached in Method Development, Validation and Degradation Profiling of Aripiprazole a Antidepressent Agent

The aim of present research work was to develop simple, precise and rapid RP-HPLC method for analysis of Aripiprazole in tablet dosage form using QbD Method. RP-HPLC method was developed for the estimation of Aripiprazole in tablet dosage form with the help of QbD approaches. The proposed methods were applied for the determination of drug in tablet dosage form. In this method concentration of each drug was obtained by using the absorptivity values calculated for drug wavelength 254nm and solving the equation. A rapid and reliable RP-HPLC method was developed and validated estimation of Aripiprazole in tablet dosage form. The RP-HPLC method was performed C18 (100mm x 4.6 mm,)2.5 μm particle size in gradient mode, and the sample was analyzed using methanol 80 ml and 20 ml (pH 3.3 0.05% OPA with TEA) as a mobile phase at a flow rate of 0.7 ml/min and detection at nm. By the retention time for Aripiprazole found 3.29 min respectively. The method was applied to marketed tablet formulations. The tablet assay was performed for combination was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation related the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots by both HPLC were linear over the 10-50μg/ml for Aripiprazole respectively, and recoveries from tablet dosage form were between 99.48 and 100.02 %. The method can be used for routine of the quality control in pharmaceuticals. The RP-HPLC method was found to be simple, economical and rapid as compared to MS method was found to be more accurate, precise and robust. Both these methods can be used for routine analysis of Aripiprazole in tablet dosage form.

Development and validation of a liquid chromatographic-quadrupole time of flight mass spectrometric method for the assay of telmisartan and hydrochlorothiazide in marketed tablet formulations

A review on biological matrices and analytical methods used for determination of drug of abuseNikhil Mali, Manisha Karpe, Vilasrao Kadam

FAST DISINTEGRATING TABLETS - A NEW ERA IN NOVEL DRUG DELIVERY SYSTEM

Among all dosage forms, fast-Disintegrating tablets are one of the most commonly used dosage forms, especially in children, because their nervous system and muscular system are not well developed compared to them in adults. and in adult patients with Parkinsons disease or hand tremors. Some fixed dosage forms, such as capsules and tablets, now have difficulty swallowing (dysphagia), which results in many cases of non-compliance and renders therapy ineffective. The most preferred routes of administration for various drugs are oral dosage forms and the oral route with specific limitations such as first-pass metabolism by the liver, psychiatric patients, at-risk patients, and non-cooperators. FDTs dissolve easily in saliva without the need for water. Fast- Disintegrating tablets dissolve in saliva in a minimum of less than 60 seconds., And these are really fast-digesting tablets. FDT formulations contain super disintegrants to increase the rate of tablet degradation in the buccal cavity. FDTs have advantages because they are easy to manufacture, have the right dosage, good chemical and physical strength, and are an ideal alternative for children and adult patients. FDTs have a faster rate of degradation, faster absorption, so that in vitro drug release time increases and this property of the drug (dosage form) increases bioavailability. FDT formulations have specific advantages in both conventional tablet and liquid dosage forms. There are many technologies for spray drying, cotton candy process, sublimation, melt granulation, direct freeze pressing / lyophilization, phase transition process, mass extrusion, etc. This overview provides brief information on FDT, including the definition, benefits, needs or requirements of FDT, key characteristics FDT, limitations, various challenges in the development of FDT, marketed tablet formulations that cause rapid digestion and so on.

A New HPLC Stability Indicating Method and Validation for Simultaneous Quantitation of Bilastine and Montelukast Sodium in API and Marketed Formulation by QbD Approach

A new HPLC stability indicating method was developed and optimized by using a statistical tool, design expert 13.0.1.0 (Stat-Ease) for simultaneous quantitation of bilastine and montelucast sodium in marketed tablet dosage form. Randomized response surface methodology with two factor central composite design was utilized for mobile phase optimization and the effect of the independent variables, flow rate and volume of organic phase on critical quality attributes, resolution and retention time was studied. The analytes were resolved on a inertsil C18 (150 × 4.6 mm) column with 5 μm particle size. Within the design space the optimum chromatographic condition chosen was 0.1% orthophosphoric acid with acetonitrile at 60:40 (%v/v) having a flow rate of 1 min/mL for 10 min. The retention time (Rt) for bilastine and montelucast sodium was 2.445 and 3.787 min, respectively. The method was completely validated as per the current ICH guidelines. Forced degradation was carried out in acidic, basic, photolytic, neutral, oxidation, thermal conditions to prove the stability indicating property of HPLC method. The method’s applicability was studied by determining bilastine and montelucast sodium in the marketed tablet dosage form. This validated RP-HPLC stability indicating method can be suggested for routine quality control analysis in industries and research laboratories for the fixed dose marketed tablet formulation.

Bioanalytical Method Development and Validation for the Estimation of Saxagliptin in Marketed Tablet Formulation

The concepts, importance and application of bioanalytical method development have been discussed for a long time and validation of bioanalytical methods is widely accepted as pivotal before they are taken into routine use. Now it is widely accepted that bioanalysis is an integral part of the clinical diagnosis, biomarker discovery, pharmacokinetic/ pharmacodynamic characterization of a novel chemical entity from the time of its discovery and during various stages of drug development, leading to its market authorization. Bioanalytical methods, based on a variety of physico-chemical and biological techniques such as chromatography, immunoassay and mass spectrometry, must be validated prior to and during use to give confidence in the results generated. This study describes the development of an innovative, rapid, precise, selective and sensitive reverse phase high-performance liquid chromatography method for the quantitative determination of Saxagliptin (SAXA) in human plasma and pharmaceutical dosage form. Extraction of drug from plasma was done by employing optimized liquid-liquid extraction procedure. The sample was analyzed using methanol: acetonitrile in the ratio of 50:50v/v as mobile phase. Chromatographic separation was achieved on Thermo C18 analytical column (250mm×4.6mm i.d., 5.0μm) as stationary phase using isocratic elution (at a flow rate of 1 ml/min). The peak was detected using UV-PDA detector set at 230 nm and the total time for a chromatographic separation was 20 min. The calibration curve obtained was linear (r2 = 0.999) over the concentration range of 5-25μg/ml for SAXA. Method was validated for precision, robustness and recovery.

Development and Validation of Ultra Performance Liquid Chromatographic Method Simultaneous Estimation of Aspirin and Ticlopidine Hydrochloride in Pharmaceutical Formulation

Objective: The combined dose tablet formulation containing aspirin and ticlopidine hydrochloride is used to reduce the formation of harmful blood clots in blood vessels which helps in preventing a heart attack or stroke in people with heart disease. The objective of the present work was to develop an accurate, precise, economical and less time consuming UPLC method and subsequently validate the method as per ICH guidelines, for routine quality control of combined dose tablet formulation containing above mentioned drug.&#x0D; Methods: The present work describes development and validation of ultra performance liquid chromatographic method for simultaneous quantitation of aspirin and ticlopidine hydrochloride in tablets. The chromatographic separation was carried out using Supelcosil LC-18 (3.3 cm × 4.6 mm × 3 µm) column using mixture of Potassium Phosphate buffer (0.01M) and Acetonitrile (20:80 v/v) as mobile phase with a flow rate of 0.6 ml per minute, total run time was 3 minutes. The detection and quantitation of chromatographic peaks was carried out at 230 nm.&#x0D; Results: The retention time for aspirin (ASP) and ticlopidine hydrochloride (TPH) was 0.529 minutes and 1.530 minutes, respectively. The linearity of detector response was observed in the concentration range of 20 – 60 µg/ml and 50-150 µg/ml for ASP and TPH, respectively. The LOD and LOQ for ASP and TPH was found to be 0.399 &amp; 1.209 and 3.385 &amp; 10.260, respectively. The accuracy of the method was found in the range of 99.92 – 100.58 % and 98.91 – 100.52 for ASP and TPH, respectively. The relative standard deviation for intra-day and inter-day precision studies was below 2 % indicating that the method is precise. The robustness of the proposed method was evaluated by varying the chromatographic parameters and the effect of these changes on retention time and tailing factor was studied. The % RSD for retention time and tailing factor was below 2 % indicating that the method is robust. The forced degradation studies were carried out to evaluate the specificity of the method. As the method was able to quantitate ASP and TPH selectively in presence of degradation products, the method was found to be specific. As the results of validation studies were within standard limits, the method was successfully applied for simultaneous estimation of ASP and TPH in marketed tablet formulation.&#x0D; Conclusion: The method has distinct advantages over reported UV and HPLC methods and hence the developed UPLC method can be used for routine quality control of Aspirin and Ticlopidine hydrochloride combined tablet formulation.