IJPAR JOURNAL

Forced Degradation Studies on Anti-Cancer Drugs: A Comprehensive Review

K. Poonkuzhali — 2025-01-06

Forced degradation studies are essential to understanding the stability, safety, and efficacy of anti-cancer drugs, playing a critical role in ensuring their reliability throughout the product lifecycle. These studies expose pharmaceutical compounds to controlled stress conditions—such as heat, light, oxidation, and hydrolysis—to simulate long-term storage and identify degradation pathways. Anti-cancer drugs, due to their intricate molecular structures and sensitivity, are particularly prone to degradation, making these studies indispensable in pharmaceutical development and regulatory compliance. This review explores the fundamental principles of forced degradation, highlights common degradation mechanisms, and discusses advanced analytical techniques used to evaluate the stability of anti-cancer drugs. Case studies of widely used therapies, including doxorubicin and paclitaxel, illustrate the challenges and mitigation strategies. Furthermore, this paper evaluates regulatory frameworks, such as ICH Q1A(R2), and examines future trends, such as artificial intelligence in predictive modelling. These insights emphasize the significance of forced degradation studies in ensuring the safety and effectiveness of anti-cancer drugs.

A Comprehensive Review on the Extraction and Determination of Vitamins and Minerals in Kodo Millet (Paspalum scrobiculatum)

B. Roja Rani — 2025-01-16

Kodo millet (Paspalum scrobiculatum) is increasingly recognized as a nutrient dense cereal with substantial potential for addressing micronutrient deficiencies. This review synthesizes current methodologies and emerging approaches in the extraction and determination of vitamins and minerals from kodo millet. Emphasis is placed on its B complex vitamins (thiamine, riboflavin, niacin) and essential minerals (iron, calcium, zinc, magnesium), which collectively offer diverse health benefits. Factors affecting nutrient retention such as antinutritional compounds (phytates, tannins), enzymatic activities, and environmental parameters are discussed in detail, underscoring the complexity of accurately quantifying micronutrients in this grain. The paper examines traditional and modern extraction techniques (solvent based, microwave assisted, enzymatic) as well as advanced analytical tools, including high performance liquid chromatography (HPLC), inductively coupled plasma mass spectrometry (ICP-MS), and other spectroscopic methods. Special attention is afforded to method standardization challenges, the importance of rigorous validation (including the use of certified reference materials), and potential pathways for biofortification and crop improvement. Moreover, the review highlights the cereal’s resilience under marginal growing conditions, aligning its cultivation with the broader goals of sustainable agriculture. By identifying knowledge gaps and proposing harmonized protocols for nutrient analysis, this article seeks to catalyze further research, promote consumer acceptance, and encourage policy support for integrating kodo millet into mainstream diets. Ultimately, leveraging its robust nutritional profile could make kodo millet a vital contributor to addressing malnutrition and advancing global food security initiatives.

Newer Rp-Hplc Method Development And Validation For The Simultaneous Estimation Of Telmisartan And Amlodipine In Dosage Form

Vanumu Anil Kumar — 2025-01-16

A novel and efficient Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method has been developed and validated for the simultaneous estimation of Telmisartan and Amlodipine in pharmaceutical dosage forms. The primary objective of this study was to establish a reliable and reproducible RP-HPLC method with optimized chromatographic conditions, ensuring the accurate determination of both drugs in combination. The method employs a Waters HPLC system equipped with an auto-sampler and a PDA Detector 996 model. The chromatographic separation was achieved using a Phenomenex Luna C18 column (4.6×250 mm, 5 µm particle size) under the following optimized conditions: the mobile phase consisted of a mixture of Acetonitrile and phosphate buffer (45:55 v/v), with a flow rate of 1 mL/min. The pH of the buffer was adjusted to 4.6 using diluted orthophosphoric acid, ensuring stability and efficient separation. The detection was carried out at a wavelength of 245 nm, and the injection volume was 10 µL. The column temperature was maintained at 35ºC to optimize the resolution and retention times of both drugs. The total run time for each analysis was 7 minutes. The method was validated in accordance with ICH guidelines for specificity, linearity, accuracy, precision, LOD, and LOQ. The results demonstrated good separation with no interference from excipients, and both drugs were found to elute with sharp peaks, ensuring accurate quantification. The method showed excellent linearity with correlation coefficients (r²) greater than 0.999 for both Telmisartan and Amlodipine in the tested concentration range. The method was successfully applied to the estimation of both drugs in commercial tablet formulations.

Development and validation of a stability-indicating rp-hplc method for simultaneous estimation of rilpivirine and cabotegravir in dosage forms

V. Sruthi — 2025-01-16

A simple, accurate, and precise method for the simultaneous estimation of Rilpivirine and Cabotegravir in pharmaceutical dosage forms was developed and validated using RP-HPLC. The analysis was performed on a Sunfire C18 column (150 mm x 4.6 mm, 5 µm) with a mobile phase of 0.1% orthophosphoric acid and acetonitrile in a 60:40 ratio at a flow rate of 1.0 mL/min. Retention times for Rilpivirine and Cabotegravir were 2.174 min and 2.815 min, respectively. Method validation demonstrated linearity, accuracy, and precision, with %RSD values below 2%, recovery rates of 99.51%-100.35%, and LOD/LOQ values of 0.38 µg/mL/1.15 µg/mL for Rilpivirine and 0.06 µg/mL/0.19 µg/mL for Cabotegravir. This stability-indicating method is efficient and economical for routine quality control in pharmaceutical industries.

Formulation and charecterization of didanisine micro beads

Nansri saha — 2025-01-27

From past few years Microbeads have been studied by many workers as a choice of novel drug delivery system to provide a better drug bioavailability considering, high penetration property of the Microbeads encapsulated agents through biological membrane and the stability of them. The present formulation study on Didanosine is an attempt to prepare Microbeads drug delivery system and evaluate its performance. The formulations were prepared, varying the ratios of polymer and sodium alginate/ sodium bicarbonate, by emulsification and ionic gelation method. An ideal or best formulation of Microbeads is the one which gives high entrapment efficiency along with good stability and drug release profile. In the present study entrapment efficiency is found to be drug and polymer ratio dependent. The release rate is found to be depended on polymer concentration and addition of the cations like Calcium chloride.

Physicochemical evaluation and Pharmacognostic Study of Panibel (Ampelocissus latifolia) (Roxb.) -Stem

Smita Soni — 2025-01-28

Ampelocissus latifolia, belonging to the Vitaceae family, is a climber plant, mostly found in the Sub-Himalayan region of India, ranging from the Sutlej eastward to Kumaon up to 4000 feet, as well as in Aasam, Konkan, Western Ghats from Bombay to Nilgiris and Anamallis Deccan. Various parts of this plant is using to treatment of the several human diseases like leaf and stem bark is useful for wound healing, whole plant is used Kustha (leprosy) and Sotha (swelling).The stem bark is used in stomach pain and bone fracture. The roots are used in skin diseases, wound healing, rheumatic affections, fractures, diuretic, gonorrhoea, syphillis, eye diseases, menstrual troubles and also as a tonic. Ethno-medicinal and therapeutic uses of Ampelocissus latifolia various parts study was undertaken. In present investigation various tools and techniques included like that pharmacognostic studies, physicochemical tests, preliminary phytochemical analysis and development of HPTLC fingerprints profile. The established parameters can be used as standards for further study and also preparation of a monograph of Ampelocissus latifolia plant stem.

Formulation development and characterization of Sustained release tablets of nicardipine

Nansri saha — 2025-01-30

The aim of this study was to develop and characterize sustained-release tablets of nicardipine hydrochloride, a calcium channel blocker used to treat hypertension and angina. Sustained-release formulations improve patient compliance by reducing dosing frequency and maintaining stable plasma drug concentrations. Nicardipine short half-life and high first-pass metabolism make it an ideal candidate for sustained-release delivery systems. The tablets were prepared using the wet granulation technique, employing various hydrophilic and hydrophobic polymers such as Xanthum gum, Guar gum as release-controlling agents. Formulations were optimized by evaluating pre-compression parameters like bulk density, tapped density, compressibility, and angle of repose, as well as post-compression characteristics such as hardness, friability, drug content, weight variation, and in vitro dissolution profiles. In vitro drug release studies were conducted in simulated gastric fluid (pH 1.2) for the initial 2 hours, followed by simulated intestinal fluid (pH 6.8) for 10 hours, using USP Type II dissolution apparatus. The release data were analyzed using kinetic models such as zero-order, first-order, Higuchi, and Korsmeyer-Peppas to determine the release mechanism. The optimized formulation demonstrated sustained drug release for up to 12 hours, following a non-Fickian diffusion mechanism. The results suggest that the combination of Xanthum gum, Guar gum provides effective control over drug release, ensuring prolonged therapeutic effects. Stability studies conducted as per ICH guidelines confirmed the robustness of the formulation. This study highlights the potential of sustained-release nicardipine tablets in improving treatment outcomes and patient adherence.

Formulation development and invitro evaluation of quinethazone sustained release oral dry syrup (ds)

Nansri saha — 2025-01-30

The aim of this present investigation was to develop Quinethazone sustained release dry syrup formulation. The formulations were evaluated for different parameters like taste evaluation, Micromeritic properties and % of drug release. It was concluded that the taste was completely masked and acceptable for patients. The taste masked syrup was prepared using three different suspending agents namely Ghatti gum, Eudragit EPO and Eudragit RLPO. The final formulation contained three different concentrations of each suspending agents. Then it was evaluated for different parameters like colour, odour, flow properties, % drug content, sedimentation volume, pH, redispersibility, viscosity and in- vitro drug release. From the results it was concluded that the formulation with suspending agent Eudragit EPO with 3% concentration showed highest sedimentation volume and better redispersibility which were very important parameter when once have to deal with syrup. The other parameters were also showed better results for the same suspending agent. So it was selected as an optimized suspending agent amongst three.

Review on medicinal activities of Phyllanthus reticulatus

S. Sathya — 2025-02-11

Medicinal plants occupy a very important place throughout the world. There are multipotential plants like Phyllanthus reticulatus, which has the capacity to cure many ailments. Herbals are a safer and more effective way to cure various problems in society. Phyllanthus reticulatus (Phyllanthaceae), commonly known as pancoli or karineli is a large genus and widely distributed in the tropical and subtropical zones like tropical Africa, tropical America, India, Sri Lanka, Southeast Asia, China, and Malaysia are all home to the plant. Scientific proof supporting the pharmacological actions of several sections of Phyllanthus reticulatus is now available after in vitro and in vivo studies. Analgesic, antibacterial, antifungal, anti-human immunodeficiency virus-1, anti-inflammatory, anti-plasmodial, hepatoprotective, and antifungal activity are among the pharmacological activities of the leaf, aerial, root, and stem. They have been used in India and have a beneficial role in Ayurveda for the treatment of digestive genitourinary, respiratory and skin diseases; Hepatitis B, hypertension, dropsy, and sore throat, jaundice, renal calculus, and malaria. The plant contains tannic acid, alkaloids, terpenoids, flavonoids, phenolic compounds, and glycosides as main chemical constituents. The goal of this article is to provide an overview of this plant pharmacological activities. When we evaluate Phyllanthus reticulatus pharmacological and therapeutic activities, we can see that it is a very good and important medicinal plant.

Formulation And In Vitro Evaluation of Controlled Release Matrix Tablets of Zidovudine

L. Jyothi Rani — 2025-02-13

Objective: This study aimed to develop and evaluate controlled-release matrix tablets of Zidovudine, with the goal of extending the drug’s release profile to enhance therapeutic efficacy and patient compliance.

Methods: Zidovudine matrix tablets were formulated using various polymers to achieve a controlled-release mechanism. The tablets were prepared through direct compression, and their physical properties—including hardness, friability, drug content, and weight uniformity—were assessed. In vitro dissolution studies were conducted under simulated gastrointestinal conditions to evaluate the release kinetics and determine the suitability of the matrix tablets for controlled drug delivery.

Results: The formulated matrix tablets exhibited satisfactory physical characteristics, including appropriate hardness and minimal friability. The in vitro dissolution studies revealed a prolonged and consistent release of Zidovudine, with the tablets demonstrating a controlled-release profile that effectively sustained drug release over an extended period. The release data indicated that the matrix tablets followed a controlled-release mechanism, with a steady drug release rate that met the desired therapeutic requirements.

Conclusion: The development of controlled-release matrix tablets for Zidovudine proved to be effective in providing a sustained release of the drug, potentially improving therapeutic efficacy and patient adherence by reducing dosing frequency. The results suggest that the matrix tablets are stable and capable of achieving the intended controlled-release profile.

Synthesis, Characterisation And Biological Evaluation Of Selenium Conjugated Naringenin Nanoparticles

A. Helen Sonia — 2025-02-17

In this study, Selenium Nanoparticles (Se-N-NPs) were synthesized by chemical reduction method using sodium salt of selenium and ascorbic acid, a reducing agent and a bioactive molecule naringenin, a bioflavonoid from citrus fruits. The sodium selenite and ascorbic were mixed together followed by conjugation with naringenin. Se-N-NPs were characterized by UV, FTIR, SEM, TEM, EDAX, X-RD and Zeta Sizer analysis. The UV spectrum indicated the highest peak of absorbance at 293 nm in acetone whereas FTIR analysis of Se-N-NPs indicated absorbance bands at 3336 cm^-1 for OH group, 2926cm^-1 for CH₃ and 1631 cm^-1 C=O group. Drug release studies proved that the NPs release the drug in sustained manned with time. The antioxidant activity of NPs was carried by DPPH method using ascorbic acid as std.. The anticancer activity was studied as MCF-7 cancer cell line by MTT assay method. The obtained result showed that NPs have IC₅₀ 260μg which proved anticancer effect of NPs. Apoptosis studies were done with dual dye AO/EB stain. This result proved that the Se-N-NPs inhibited cancer cell growth by inducing apoptosis. Comprehensively it can be concluded that Se-N-NPs can be attempted to develop a nano formulation with anti-cancer potential. However, extensive research is needed to reach a concrete conclusion.

A review on analytical methods for the estimation of carisoprodol in bulk and its formulations

M. Narendra — 2025-02-17

This review focuses on the analytical methods for the estimation of carisoprodol in bulk and its pharmceutical preperations. Carisoprodol is a centrally acting skeletal muscle relaxant widely used to alleviate acute musculoskeletal pain. It is metabolized into meprobamate, which contributes to its therapeutic effects. I mentioned the drug profile and chemical structure of carisoprodol and introduction, mechanism of action, pharmacokinetics and some Analytical techniques are used to detect the quantitative and qualitative analysis such as UV-Spectroscopy, High-Performance Liquid Chromatography (HPLC), Thin Layer Chromatography (TLC),Gas chromatography (GC), Capillary electrophoresis (CE) and Fourier Transform Infrared Spectroscopy (FTIR) by each method I have mentioned some authors and they getting parameter values have been applied to determine Carisoprodol's precision, accuracy, linearity, and sensitivity.

Formulation and evaluation loaded nanoparticles of dorzolamide hydrochloride

B. Rama — 2025-02-23

Objective: The study aimed to formulate and evaluate Dorzolamide Hydrochloride-loaded nanoparticles to enhance ocular bioavailability and therapeutic efficacy. The formulation utilized Eudragit RSPO and Poloxamer 188 as polymers to optimize nanoparticle characteristics and drug release profiles.

Methods: Dorzolamide Hydrochloride nanoparticles were prepared using a nanoprecipitation technique involving Eudragit RSPO and Poloxamer 188. Various formulation parameters were optimized to achieve the desired particle size, drug loading capacity. The nanoparticles were characterized for their physical properties, including size, and zeta potential. In-vitro drug release studies were conducted to evaluate the release profile of the drug from the nanoparticles.

Results: Among the different formulations tested, the formulation with Eudragit RSPO and Poloxamer 188 F2 exhibited the most favorable characteristics. The F2 formulation achieved an in-vitro drug release of 99.37%, indicating a high release efficiency and sustained release profile. This formulation was considered optimal based on its drug release performance and stability.

Conclusion: The developed Dorzolamide Hydrochloride-loaded nanoparticles using Eudragit RSPO and Poloxamer 188 demonstrated excellent drug release characteristics. The F2 formulation, with its high in-vitro release rate, holds promise for improving the ocular delivery of Dorzolamide Hydrochloride, potentially enhancing its therapeutic efficacy and reducing side effects associated with conventional dosage forms.

A Review On Rp-Hplc

A. Rajareddy — 2025-03-04

Chromatography is largely used in chemical analysis, where High- performance liquid chromatography (HPLC), a very flexible approach, is used to separate analytes by passing them through a column filled with micrometer-sized particles. Chromatography is essentially a separation technique. Now a days, the most popular separation method in HPLC is reversed-phase chromatography. This is due to the reversed phase method's ease of use, adaptability, and range, which allow it to handle compounds with a wide range of molecular masses and polarities. In the field of biological separation and purification, reversed phase chromatography has been used for both analytical and preparative purposes. Proteins, peptides, and nucleic acids are examples of molecules with some degree of hydrophobicity that can be separated using reversed phase chromatography with good recovery and resolution. In addition to providing a brief overview of the crucial chromatographic parameters that must be optimized for an effective method development, this paper discusses the significance of RP-HPLC in analytical method development and their techniques.

Assessment of reproductive and developmental toxicity risks of cobalt in medical devices

M. Nikhitha — 2025-03-12

Cobalt metal is an essential trace element that plays a crucial role in various biological processes, with human exposure arising from diverse sources, including diet, dietary supplements, occupational environment, medical devices. Recently, the European Chemicals Agency (ECHA) classified cobalt as a Reproductive Hazard Category 1B. This classification indicates that cobalt is presumed to be a reproductive toxin, primarily due to adverse effects on the testes in male rodents during clinical trials. To evaluate the significance of this classification. Findings from these evaluations suggest that cobalt-induced reproductive toxicity in rodents is confined to the testes function. The underlying mechanisms of cobalt's reproductive effects, including indirect impacts on testicular function, are discussed in the context of their applicability to human health. Notably, current evidence suggests that the classification of cobalt as a Reproductive Hazard Category 1B may not be entirely appropriate. Instead, a more fitting classification might be as a Reproductive Hazard Category 2, indicating a reproductive toxin. Importantly, for cobalt-containing medical devices, the data do not support its classification as a reproductive hazard, highlighting the need for a refined, evidence-based perspective in regulatory assessments.

Pathophysiology of Hutchinson Gilford Progeria Syndrome: Current Knowledge and Future Directions

Gautam Ponnaganti — 2025-03-17

Hutchinson-Gilford Progeria Syndrome (HGPS) is a rare genetic disorder characterized by accelerated aging in children. It was first described by Jonathan Hutchinson in 1886 and later independently by Hastings Gilford in 1897. Children with HGPS typically exhibit growth retardation, loss of body fat and hair, skin changes, joint stiffness, and severe cardiovascular complications. The disorder is caused by a mutation in the LMNA gene, which encodes lamin A, a protein essential for maintaining the structural integrity of the cell nucleus. This mutation leads to the production of an abnormal form of lamin A, called progerin, which disrupts nuclear architecture and cellular function, resulting in the premature aging phenotype observed in HGPS.

Methods: We conducted a comprehensive search from April to June 2024 using PubMed and Google Scholar. Keywords used ("Hutchinson-Gilford Progeria Syndrome" OR Progeria) AND (pathophysiology OR "genetic disorders" OR "LMNA gene mutation" OR "Lamin A protein" OR "nuclear envelope" OR "cardiovascular complications" OR "clinical features" OR "molecular mechanisms" OR "therapeutic approaches"). The review included peer-reviewed original research papers, systematic reviews, and meta-analyses.

Conclusion: HGPS is characterized by premature aging due to a mutation in the LMNA gene. Despite progress in understanding its molecular mechanisms and improving clinical management, significant obstacles remain due to the rarity of the condition and ethical considerations in research and treatment. Future research should aim to advance therapeutic strategies through innovative approaches.