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  • Open Access Icon
  • Research Article
  • 10.69857/joapr.v14i2.2078
Integrated LC–MS/MS bioanalysis for the simultaneous quantification of metformin HCl, pioglitazone HCl, and teneligliptin HBr hydrate in human plasma
  • Mar 15, 2026
  • Journal of Applied Pharmaceutical Research
  • Sejal H Pandya + 1 more

Background: Combination therapy is widely prescribed in Type II diabetes mellitus to maintain effective glycemic control. The rising use of multidrug regimens demands selective and reliable bioanalytical methods capable of simultaneously quantifying multiple antidiabetic agents in human plasma for pharmacokinetic and bioequivalence studies. Methodology: A rapid, sensitive, and cost-effective LC–MS/MS method was developed and validated in accordance with ICH M10, USFDA, and EMA guidelines for the simultaneous estimation of metformin hydrochloride, teneligliptin hydrobromide hydrate, and pioglitazone hydrochloride. The assay enabled triple-drug quantification within a single 7-minute chromatographic run, showing an estimated 12–40% reduction in analysis time versus previously reported 8–15-minute single- or dual-analyte methods. Separation was achieved on a Cosmosil CN column (150 × 4.6 mm, 5 μm) using 10 mM ammonium acetate and acetonitrile (40:60 %v/v). Plasma samples were prepared by protein precipitation followed by liquid–liquid extraction, and detection was performed in positive electrospray ionization multiple-reaction-monitoring mode. Results and Discussion: Strong linearity was obtained for all analytes (r² > 0.995). LLOQs were 10.0 ng/mL for metformin, 1.25 ng/mL for teneligliptin, and 5.0 ng/mL for pioglitazone. Metformin-D6 served as the internal standard for metformin, while saxagliptin was used as the internal standard for teneligliptin and pioglitazone to ensure appropriate normalization across chemical classes. Precision remained below 10% CV, recovery was consistent, and stability stayed within ±15% under tested conditions. Reduced runtime and unified multi-analyte detection improved analytical throughput and minimized solvent consumption without compromising regulatory compliance. Conclusion: The validated LC–MS/MS method provides a reliable, resource-efficient platform for concurrent quantification of combined antidiabetic drugs in pharmacokinetic, bioequivalence, and clinical studies.

  • Open Access Icon
  • Research Article
  • 10.69857/joapr.v14i2.1942
Phytochemical characterization and antibacterial potential of Spirulina platensis
  • Mar 15, 2026
  • Journal of Applied Pharmaceutical Research
  • Arpitha Mp + 2 more

Background: Algae are among the most diverse types of organisms on the planet. They have many advantages for humans. The most significant one is blue-green algae, which contain bioactive compounds, such as those found in Spirulina platensis. Methodology: The present study examines the antibacterial properties and phytochemical composition of Spirulina platensis, isolated from different freshwater bodies in the Chitradurga district, Karnataka, India. Results & Discussions: The anti-bacterial activity of the selected bacterial strains was investigated, and some appropriate results were found, which are discussed in the following sections. The methanolic extraction has revealed the maximum activity and the highest inhibition zones against E. coli and P. aeruginosa, followed by the acetone and the hexane extracts. The GC-MS profile examined has shown a range of bioactive compounds, viz., hexadecenoic acid, methyl esters, n-hexadecenoic acid, and glycerine. The occurrence of these compounds represents glycerine, ester compounds & lipid-derived metabolites, and the aromatic metabolites produced have the potential to exhibit antibacterial activity by S. platensis. It has the highest potential in the pharmaceuticals, nutraceuticals, and biotechnologies. Conclusions: The presence of these substances suggests that glycerine, esters, and aromatic compounds act in concert to produce potentially broad antibacterial activity by S. platensis. It can be inferred that the methanolic extract has shown high bioactivity.

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  • Research Article
  • 10.69857/joapr.v14i1.1229
Design and evaluation of amphotericin b and luliconazole nanoemulsions for targeted antifungal delivery
  • Jan 4, 2026
  • Journal of Applied Pharmaceutical Research
  • Pravin N Kirdat + 1 more

Background: Drugs like Amphotericin B and Luliconazole, which are poorly soluble in water and undergo significant first-pass metabolism, often show low bioavailability. Using nanoemulsion-based delivery systems can enhance absorption and efficacy in the treatment of fungal infections. This study aimed to develop and optimize nanoemulsion formulations of Amphotericin B and Luliconazole to improve their solubility and stability and to demonstrate potential for enhanced bioavailability. Methods: Preliminary characterization of Amphotericin B and Luliconazole included solubility analysis in various solvents, melting point determination, particle size, zeta potential, FTIR spectroscopy, DSC, and XRD. Amphotericin B was further evaluated using a validated RP-HPLC method and subjected to forced degradation studies. Pseudo-ternary phase diagrams were constructed to identify suitable Smix ratios for nanoemulsion formation. Formulations were prepared by homogenization and optimized using a central composite design. Key variables included globule size, zeta potential, homogenization speed, and time. Results and Discussion: The optimized Amphotericin B nanoemulsion (NE-02-8) exhibited a globule size of 168.2 nm, zeta potential of –28.9 mV, PDI of 0.578, drug content of 99.28%, and 99.48% transmittance. Statistical optimization using a Central Composite Design (CCD) confirmed that homogenization speed and time significantly influenced globule size (p < 0.05) and zeta potential (p < 0.05). In contrast, the Luliconazole nanoemulsion showed a globule size of 327.5 nm and a zeta potential of –27.9 mV. Conclusion: Nanoemulsion formulations of Amphotericin B and Luliconazole demonstrated enhanced solubility, stability, and physicochemical properties, indicating their potential to improve drug solubilization and stability relative to conventional formulations.

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  • Research Article
  • 10.69857/joapr.v13i6.1488
Thermal sintering driven modulation of drug release and buoyancy characteristics in dasatinib gastro-retentive tablets
  • Dec 25, 2025
  • Journal of Applied Pharmaceutical Research
  • Chandan Mohanty + 4 more

Background: Thermal sintering is emerging as an innovative and cost-effective technique in pharmaceutical formulation design, especially for controlling drug release in oral dosage forms. This study investigates its applicability in the development of gastro-retentive floating tablets for Dasatinib, a tyrosine kinase inhibitor with low solubility and bioavailability. Methodology: Floating matrix tablets were developed via direct compression, incorporating carnauba wax and hydroxypropyl methylcellulose as matrix-forming agents, along with sodium bicarbonate as a gas-generating component to impart buoyancy. The tablets were then thermal-sintered at two temperatures for varying durations in a controlled hot-air oven. The effects of thermal sintering conditions were investigated with respect to in vitro dissolution, mechanical strength, percent water uptake, percent erosion, total buoyancy duration, floating lag time, and SEM morphology. Results and Discussion: Statistical analysis using two-way ANOVA (α = 0.05) revealed that sintering condition significantly influenced drug release and buoyancy performance (p < 0.01). Formulation DST 02 sintered at 70°C-3 hours exhibited optimal performance, achieving a maximum drug release of 96.3% over 13 hours. Characterization technique methods such as FTIR and DSC have confirmed the absence of chemical interactions and polymorphic transitions. Stability studies conducted in accordance with ICH guidelines indicated that the optimized formulation remained stable throughout the study period. Conclusion: Thermal sintering effectively modulated the release characteristics of Dasatinib from floating tablets, thereby increasing gastric retention time and facilitating sustained drug release. This technique holds promise for improving therapeutic efficacy, reducing dosing frequency, and enhancing patient compliance in oral drug delivery.

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  • Research Article
  • 10.69857/joapr.v13i6.1503
Gastroprotective potential of Dolichandrone falcata extract via modulation of oxidative stress, inflammation, and mucosal healing
  • Dec 25, 2025
  • Journal of Applied Pharmaceutical Research
  • Sagar Kamble + 4 more

Background: Dolichandrone falcata, traditionally used for gastrointestinal disorders, has demonstrated antiulcer activity, but the underlying protective mechanisms remain unclear. This study evaluated the methanolic extract of D. falcata for gastroprotective, antioxidant, and anti-inflammatory activities using ethanol- and pylorus-ligation–induced ulcer models in rats. Methodology: Wistar rats were divided into control, standard, and treatment groups. Ulcers were induced by ethanol or pyloric ligation. The extract (100, 200, and 400 mg/kg) and omeprazole (20 mg/kg) were administered orally. Ulcer index, gastric parameters, oxidative stress markers [malondialdehyde (MDA), glutathione (GSH), superoxide dismutase (SOD), catalase (CAT)], and inflammatory cytokines [TNF-α, IL-6] were assessed, supported by histopathological examination. Results and Discussion: The extract produced a dose-dependent reduction in the ulcer index in both models, with 76.6% protection at 400 mg/kg, comparable to omeprazole (79.7%). Histology revealed marked restoration of the gastric mucosa with minimal necrosis. MDA levels decreased significantly, while GSH, SOD, and CAT levels were elevated toward normal. TNF-α and IL-6 were markedly suppressed, indicating a reduction in oxidative and inflammatory injury. Conclusion: D. falcata extract demonstrated potent gastroprotective effects through antioxidative, anti-inflammatory, and mucosal-healing mechanisms. This is the first biochemical and cytokine-based validation of its traditional use, suggesting strong potential for developing D. falcata as a plant-derived therapeutic for ulcer management.

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  • Research Article
  • 10.69857/joapr.v13i6.1447
Development of expeditious RP-HPLC method for simultaneous estimation of bilastine and montelukast in fixed dosage combination
  • Dec 25, 2025
  • Journal of Applied Pharmaceutical Research
  • Revathi Boddu + 4 more

Background: Bilastine and montelukast are used to treat allergic rhinitis and chronic urticaria. Due to the recent increase in highly allergic disorders, demand for this combination has risen. Therefore, for regular quality control analysis, a new, rapid, and cost-effective method has become crucial. Compared with the previously reported methods, the present method is ultra-fast, with well-separated peaks within ̴ 3.0min and a total run time of 8 min. Because it uses a methanol-buffer system, it is less expensive, more environmentally friendly, and safer than an acetonitrile-based method. This study presents a rapid, specific, and economical “reversed-phase high-performance liquid chromatography (RP-HPLC)” method for the simultaneous estimation of Bilastine and Montelukast. Methodology: The chromatographic conditions for the separation of drugs are achieved by leveraging a tailored composition of mobile phase with methanol and acidic phosphate buffer with a volume ratio of 55:45v/v, the “Zorbax C18 column (4.6×150mm, 5µ)” maintained at 35ºC with an optimized flow rate of 1.0 mL/min and detected at a wavelength of 260 nm. The injection volume is 10 µL, and the run time is 8 min. Results and Discussion: The retention times for the drugs bilastine and montelukast are 2.061 and 2.462 min, respectively. Linearity is observed with correlation coefficients of 0.9993 and 0.9994, respectively, for montelukast and bilastine at 1-5 µg/mL and 100-500 µg/mL. Efficient separation and quantification of these two therapeutically important compounds were achieved in this method. Conclusion: The developed analytical method has been validated in accordance with International Conference on Harmonisation (ICH) guidelines, demonstrating satisfactory performance with respect to specificity, accuracy, precision, linearity, and robustness. This novel RP-HPLC approach provides a valuable tool for pharmaceutical analysis and quality control.

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  • Research Article
  • 10.69857/joapr.v13i6.1815
Ameliorative potential of coumaric acid and imeglimin against reserpine-induced parkinsonism in rats
  • Dec 25, 2025
  • Journal of Applied Pharmaceutical Research
  • Yogita R Bagul + 2 more

Background: Parkinson’s disease involves dopaminergic degeneration, oxidative stress, and α-synuclein aggregation. Reserpine-induced Parkinsonism mimics these deficits via VMAT-2 inhibition. Coumaric acid and imeglimin possess antioxidant and mitochondrial-protective actions. This study evaluated the individual and combined efficacy of these agents in reducing reserpine-induced behavioural and neurochemical impairments in rats. Methodology: PD was induced in rats by giving reserpine (1 mg/kg, s.c) alternately for three days. Pretreatment with coumaric acid (80 and 100 mg/kg, p.o.), imeglimin (100 & 200 mg/kg, p.o.), and their combination were administered for 5 days. Behavioral assessments (orofacial dyskinesia, H & B test, and rotarod) were performed on day 5, followed by biochemical oxidative stress parameters (CAT, GSH, SOD, and LPO), neurotransmitters (dopamine), and α-synuclein expression with histopathological evaluations. Results: Reserpine-treated rats exhibited pronounced orofacial dyskinesia, reduced motor coordination, dopamine depletion, elevated oxidative stress, and α-synuclein expression. Pretreatment with coumaric acid and imeglimin improved behavioral outcomes, restored antioxidant enzymes, reduced inflammation, and elevated dopamine levels. Combination therapy produced the greatest improvement. Discussion: The combined effects of coumaric acid and imeglimin likely counteract reserpine-induced dopaminergic toxicity through antioxidant enhancement and inhibition of α-synuclein expression. Conclusion: Coumaric acid and imeglimin combination therapy significantly mitigates reserpine-induced Parkinsonism by improving general neuronal integrity and brain function.

  • Open Access Icon
  • Research Article
  • 10.69857/joapr.v13i6.1346
Comparative phytochemical and antioxidative profiling of assamese culinary for developing antiarthritic polyherbal formulation
  • Dec 25, 2025
  • Journal of Applied Pharmaceutical Research
  • Nilutpal Hazarika + 2 more

Background: Rheumatoid arthritis (RA) is a chronic inflammatory disorder where oxidative stress plays a critical role in disease progression with severe co-morbidities. Therefore, plant-derived bioactive compounds are increasingly explored due to their safety, affordability, and multi-targeted therapeutic properties. The present study aimed to comparatively evaluate four commonly used Assamese culinary herbs, Curcuma longa, Zingiber officinale, Piper nigrum, and Cinnamomum tamala for their phytochemical profile and antioxidant potential to identify candidates for synergistic anti-arthritic formulations. Methodology: Ethanolic extracts of the selected herbs were analyzed for TPC, TFC, and TTC using spectrophotometric assays, and bioactive constituents were identified via high-resolution LC-MS. Antioxidant activity was assessed using the DPPH and ABTS radical-scavenging assays. Data were statistically analyzed using one-way ANOVA followed by Tukey’s test (p<0.05). Result and Discussion: Among the tested herbs, turmeric showed markedly higher phytochemical content (TPC: 377.50±4.50 mg GAE/g, TFC: 294.29±2.18 mg CE/g, TTC: 201.25±3.14 mg TAE/g). HR-LCMS revealed characteristic compounds including curcumin (C. longa), 6-gingerol (Z. officinale), Dipiperamide E (P. nigrum), and eugenol (C. tamala). Antioxidant assays confirmed C. longa’s superior free-radical scavenging activity (DPPH IC50: 64.83±0.49 µg/ml; ABTS IC50: 145.60±0.95 µg/ml). Z. officinale, P. nigrum, and C. tamala extracts exhibited moderate but complementary activity profiles. Conclusion: The comparative phytochemical and antioxidant profiling demonstrated that C. longa was the most potent candidate, with Z. officinale, P. nigrum, and C. tamala exhibiting supportive bioactivity. The integrative evidence substantiated the rational design of synergistic polyherbal formulations targeting oxidative stress & inflammation in RA, with potential application in therapeutic development.

  • Open Access Icon
  • Research Article
  • 10.69857/joapr.v13i6.1405
Formulation and evaluation of flucytosine-loaded nanoemulgel for enhanced antifungal activity through in vitro and in vivo studies
  • Dec 25, 2025
  • Journal of Applied Pharmaceutical Research
  • Rajat Srivastava + 1 more

Background: Fungal skin infections constitute a prevalent global health issue, accompanied by increasing resistance to traditional antifungal medications. Flucytosine, a pyrimidine analogue exhibiting potent antifungal properties, is constrained in topical use due to inadequate skin absorption and fast elimination. Nanoemulgels, which integrate nanoemulsions with gels, enhance solubility, penetration, stability, and prolonged release, representing a viable approach for topical antifungal administration. Methods: The nanoemulgel was prepared utilizing Carbopol 940 as the gelling agent. The formulations (NEG1–NEG8) were evaluated for physical appearance, pH, viscosity, spreadability, drug content, and in vitro drug release and release kinetics. Antifungal activity was assessed by zone-of-inhibition assays and in vivo using Wistar rats infected with Candida albicans. Skin irritation, histopathology, and a three-month stability study were also conducted. Result and Discussion: The improved NEG5 formulation had a favorable pH (5.92±0.03), high drug content (95.3±1.83%), and maximum cumulative drug release (92.97±5.91% at 24 hours) with first-order release kinetics (R2= 0.9959). The commercial luliconazole cream and NEG5 showed increased antifungal effectiveness in vivo, with lesion clearance by Day 14. The histopathology showed tissue repair with minimal inflammation. NEG5 surpassed other formulations in zone-of-inhibition assays for antifungal activity. No skin irritation was reported, and the formulation was stable for three months under various storage conditions. The improved physicochemical and therapeutic performance of NEG5 suggests enhanced skin penetration and sustained drug release, addressing the limitations of conventional flucytosine therapies. Conclusion: Flucytosine-loaded nanoemulgel (NEG5) offers a promising, effective topical treatment for fungal skin infections with improved drug delivery and patient safety.

  • Open Access Icon
  • Research Article
  • 10.69857/joapr.v13i6.1483
Evaluation of Allium sativum polysaccharides as an adjunct to metformin in streptozotocin induced diabetic rats
  • Dec 25, 2025
  • Journal of Applied Pharmaceutical Research
  • Himangshu Deka + 4 more

Background: Metformin is widely prescribed for the management of diabetes; prolonged intake of metformin at higher doses is often associated with several mild to severe side effects. In recent years, plant polysaccharides have been rigorously studied for their antidiabetic properties. In this study, the complementary effect of Allium sativum polysaccharides with metformin was investigated in STZ-induced Wistar rats. Methodology: The rats were divided into five groups (n=6): normal control, diabetic control, metformin-treated (100 mg/kg b.w.), and metformin + ASP (50 mg + 200, 100 mg/kg b.w.). For 28 days, FBG and body weight were monitored. After 28 days, the rats were euthanized, and liver function markers were measured. Results and Discussion: Compared with diabetic control, combination therapy with metformin (50 mg) and ASP (200 mg) resulted in a significant reduction in glucose levels from 324.09 ± 2.90 to 125.84 ± 3.37 mg/dL. Similarly, the combination of Met 50 mg + 100 mg ASP lowered FBG levels to 178.96 ± 3.53 mg/dL. The results of a 2-way ANOVA indicated a significant interaction between the row and column factors (F(16, 125) = 192.6, p < 0.0001). Both combination therapies led to an initial decrease in body weight by day 7, followed by a subsequent recovery by day 28. In liver function test, both the combination therapies reduced AST (p < 0.05) and ALP enzyme levels (p < 0.05). Conclusion: The investigated combination therapy showed antidiabetic activities by improving glucose metabolism and liver function in rats.