Journal of Applied Pharmaceutical Sciences and Research

Development and Validation of a Stability-Indicating RPHPLC Method for the Quantitative Determination of Tegoprazan in Bulk Drug and Pharmaceutical Dosage Forms

2026-06-03T10:59:05+0530

Objective: The current study objective was to develop and validate a simple, rapid, and stability-indicating RP-HPLC method for the quantitative determination of tegoprazan in bulk drug and pharmaceutical formulations.
Materials & Methods: The chromatographic separation was achieved on Waters XBridge C18 column (250 × 4.6 mm, 5 μm) using acetonitrile and 0.02 M potassium dihydrogen phosphate buffer (60:40, v/v) adjusted to pH 5.2 at 1.0 mL/min as mobile phase. Detection was carried out at 303 nm with a total run time of 6 min. In the optimized conditions, tegoprazan display sharp and symmetrical peak at a retention time of approximately 2.5 min.
Results: The developed method produces excellent linearity over 10–60 μg/mL with a regression coefficient (R²) of 0.9994. The limits of detection (LOD) and quantification (LOQ) were noticed to be 0.03 μg/mL and 0.10 μg/mL, respectively indicates high sensitivity of the method. Precision studies produce %RSD values of <2%, proves good repeatability and intermediate precision. Accuracy assessed by recovery studies at 50%, 100%, and 150% levels yields recoveries between 98.30% and 101.11%. Robustness evaluation demonstrates minimal variation (<2%) upon small deliberate changes in chromatographic parameters. The forced degradation studies reveal that tegoprazan was most susceptible to acidic conditions and display good stability under oxidative, thermal, and photolytic stress. The method was successfully applied to the analysis of a commercial formulation with an assay value of 99.52%.
Conclusion: The developed method was simple, accurate, precise, and stability-indicating and suitable for routine quality control as well as stability analysis of tegoprazan in bulk drug and pharmaceutical dosage forms.

Development, Validation, and Forced Degradation Evaluation of a Green Stability-indicating RP-HPLC method for Upadacitinib in Bulk and Tablet Dosage Forms

2026-06-03T10:54:54+0530

Objective: The current study was to develop a simple, rapid, and reliable RP-HPLC method was proposed for the quantification of Upadacitinib in bulk drug and pharmaceutical dosage forms.
Materials & Methods: Separation was achieved on C18 column using ethanol and 10 mM ammonium acetate in 60:40 (v/v) at isocratic flow rate of 0.5 mL/min over 6 min runtime. The method produces sharp and well-resolved peak with 2.8 min retention time. It displays excellent specificity, with no interference from excipients.
Results: System suitability results were within acceptable limits, with tailing factor of 1.03 and 5813 theoretical plates indicates good column efficiency. The method demonstrates high sensitivity, with LOD and LOQ values of 0.025 μg/mL and 0.082 μg/mL, respectively. A strong linear response was noticed over 30-105 μg/mL (r² = 0.9999). Precision was proved with %RSD values of 0.49 (intra-day) and 0.60 (inter-day), while accuracy was observed in the range of 99.38 % to 100.47%. The method remains stable under small deliberate variations proves its robustness and ruggedness. The forced degradation studies show highest degradation under peroxide (8.76%), and acidic (4.75%), while drug remains stable under basic (3.81%) conditions, thermal (5.07%) and photolytic (2.12%) stress. No interference from degradation products was observed proves its stability-indicating capability. The assay was noticed to be 99.12 % and demonstrates suitability for routine quality and stability assessment of Upadacitinib. The sustainability of the method was evaluated with the use of
the AGREE (0.82), and GAPI (4.8E+02), displayed in the center corresponds to the E-factor of 475, meaning that approximately 475 g of waste is generated per gram of analyte analyzed.
Conclusion: Overall, the results demonstrate the ability of the method to maintain a good balance between analysis reliability, environmental effects, and operational convenience.

DEVELOPMENT AND EVALUATION OF CURCUMIN LOADED IN SITU GEL USING N-ACYL CHITOSAN DERIVATIVE FOR ULCERATIVE COLITIS

2026-06-12T16:36:28+0530

This study demonstrates the modification of chitosan into N-Butyryl chitosan, N-Octanoyl chitosan, N-Lauryl chitosan, and N-Palmitoyl chitosan. These modified chitosan’s were synthesized and characterized using FTIR, XRD, and DSC to confirm the successful attachment of the acyl groups at the amino position. The N-acylated chitosan’s were then loaded with the drug curcumin and evaluated for drug loading capacity and swelling index. It was observed that as the carbon chain length increased, solubility also improved, leading to a higher swelling index. The insitu gelling system was compressed into tablets and enterically coated. Invitro release studies were conducted by exposing the gel to both acidic and basic environments. The enteric coating prevented drug release in the acidic environment, while in phosphate buffer at pH 6.8, drug release occurred. These findings suggest that hydrophobically modified acylated chitosan can be effective for achieving sustained drug release, controlled by the acylation modification.

QUALITY BY DESIGN APPROACH FOR DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF FUROSEMIDE IN BULK AND FORMULATION

2026-06-12T16:37:21+0530

Background: A common loop diuretic used to manage edema, CHF, and hypertension is furosemide. The majority of described HPLC techniques for its estimation are linked to longer run times and higher solvent consumption, and they lack a systematic Quality by Design (QbD) approach. Objectives: Using a QbD methodology, the current work sought to design and validate a reliable, quick, and economical HPLC technique for furosemide quantification in pharmaceutical formulations and bulk. Materials and Methods: A central composite design was used to improve crucial procedure parameters like flow rate and mobile phase composition. Chromatographic separation was carried out using a column C18 with acetonitrile and 0.1% OPA (70:30 v/v) as the mobile phase at a flow rate 0.8 mL/min and detection at 277 nm. In compliance with ICH Q2(R1) standards, the developed method was verified for linearity, accuracy, precision, robustness, ruggedness, LOD, and LOQ. Results: With a correlation coefficient (R2) of 0.9994, the method show outstanding linearity over the range of 5–30 ppm. Precision studies indicated %RSD values below 2%, while accuracy studies showed recovery between 98–102%. It was discovered that the approach was strong and resilient, with little change under various circumstances instruments. The results showed that the LOD and LOQ were 0.65 µg/mL and 1.97 µg/mL, respectively. Summary: The new QbD-based RP-HPLC method is simple, precise, and appropriate for routine quantitative analysis of furosemide in bulk and medicinal dose forms.

Keywords: Central composite design, Furosemide, high performance Liquid chromatography, quality by design.

DEVELOPMENT AND CHARACTERIZATION OF FLOATING SUSTAINED-RELEASE TABLETS OF AN ANTI-DIABETIC DRUG

2026-06-15T10:16:12+0530

ABSTRACT: The present work focuses on Prototype Formulation with regards to development and evaluation of a sustained release floating tablet of glibenclamide for improved management of type 2 diabetes mellitus. Glibenclamide is known for its poor solubility, short half-life, and narrow therapeutic index, which often cause fluctuations in blood drug levels when taken in standard forms. To overcome these issues, Developed The gastroretentive floating system using hydrophilic polymers (HPMC K4M and K15M) along with effervescent agents like sodium bicarbonate and citric acid. The tablets were made by direct compression and tested for key properties such as hardness, friability, weight consistency, swelling behavior, floating lag time, and total floating duration. Dissolution studies were performed in 0.1N HCl using USP II apparatus. A 3² factorial design was applied to optimize polymer and gas-generating agent concentrations. The best formulation showed quick buoyancy with minimal lag, remained afloat for up to 15 hours, and released about 78–85% of the drug over 8 hours. The release pattern followed a non-Fickian diffusion mechanism, involving both drug diffusion and polymer erosion. Risk assessment using FMEA emphasized the need for a precise balance between polymer and effervescent agent levels to achieve the desired floating and release characteristics. Overall, the developed floating tablet improved gastric retention, ensured sustained release, and enhanced the therapeutic effect of glibenclamide, offering a promising strategy for better glycemic control in type 2 diabetes.

KEYWORDS: Gastroretentive Floating drug delivery, HPMC K4M and K15M, Glibenclamide, Factorial Design, non-Fickian diffusion mechanism.

Development of Quality Control Parameters and Deciphering Phytochemical Profile of the Messua Ferrea Linn Stamens

2026-06-18T12:30:15+0530

Introduction: ‘Nagakesara’ aka ‘Cobra’s saffron’ is recommended in many ayurvedic remedies, consisting of dried stamens of Mesua ferrea Linn (Fam. Calophyllaceae). Thus, we aimed to develop a comprehensive quality control toolkit for M. ferrea stamen to ensure its identity, purity, consistency and mitigate adulteration.

Materials and Methods: Collection, authentication, and pulverization of the stamens of M. ferrea was done for the determination of the physiochemical, qualitative and quantitative phytochemicals, HPLC and LC-MS fingerprint, as well as secondary-metabolites in the stamen extract in view of World Health Organization (WHO) and Indian Herbal Pharmacopoeia.

Results: Collected stamens of M. ferrea were authenticated by the Botanical Survey of India. Determined physicochemical attributes of the authenticated powdered stamens were found within the permissible limits. Yield of the hydroalcoholic extract of the stamens was found to 18.26 % w/w and was found enriched in secondary metabolites viz., alkaloids, glycosides, coumarin, phenols, tannins, flavonoids, terpenoids, saponins, carbohydrates, phytosterols and amino acids. Quantified total phenolic, flavonoid and carbohydrate content were found to be 284.24 ± 8.18 μg equivalent of gallic acid/ mg, 242.52 ± 8.36 μg equivalent of quercetin/ mg and 92.34 ± 2.58 μg equivalent of glucose/ mg of extract, respectively, Further, HPTLC and LC-MS fingerprint profile of the extract were developed. Twenty phytochemicals were identified by the generated LC-MS data.

Discussion: Established physicochemical, qualitative and quantitative phytochemical, chromatographic fingerprints and identified phytochemical profile of the M. ferrea stamens would serve as definitive tools for quality control and assurance measures by the regulatory authorities.

A G PROTEIN COUPLED RECEPTORS IN DRUG DEVELOPMENT: UNVEILING THE ROLE OF THE ORPHAN GPCRs

2026-06-12T16:34:22+0530

ABSTRACT

G protein-coupled receptors (GPCRs) represent the largest superfamily of cell emphasizing that they represent an important area that could play a significant role in future pharmacological research and therapeutic discovery. Surface membrane receptor and are encoded by approximately 1000genes.Theyplayacrucial role in various physiological processes and are among the most common drug targets. This study provides a comprehensive overview of the current understanding and advancements in GPCR research, with a particular focus on orphan GPCRs. The document begins by introducing the structural and functional aspects of GPCRs, highlighting their diversity and the importance of recent breakthroughs in structural biology techniques, such as X-ray crystallography and cryo-electron microscopy. It then delves into the historical development of the receptor concept and the discovery of GPCRs, tracing the evolution of our understanding of their signaling mechanisms. A significant portion of the study is dedicated to the exploration of orphan GPCRs, which are a subset of GPCRs that lack identified endogenous ligands. The document discusses the challenges and opportunities associated with these receptors, including their potential as novel drug targets, their involvement in diverse disease states, and the innovative approaches being employed to deorphanize and characterize them. The study also examines emerging trends in GPCR research, such as the utilization of allosteric modulators, biased signaling, and the integration of computational methods like machine learning. These advancements hold promise for enhancing our understanding of GPCR function and facilitating the development of more selective and effective therapeutic agents. Overall, this comprehensive review highlights the pivotal role of GPCRs in drug development and the significant potential of orphan GPCRs as a frontier for future pharmacological research and therapeutic discoveries.

KEYWORDS: GPCRs (G protein-coupled receptors), Orphan GPCRs, Drug targets, Structural biology, Signaling mechanisms