Journal of Pharmacreations

A Review on RP HPLC Estimation Techniques for Epirubicin and Docetaxel in Bulk and Dosage Forms

Raja Reddy Aleti — 2025-09-27

Epirubicin(10-(4-amino-5-hydroxy-6-methyl-oxan-2-yl)oxy-6,8,11-trihydroxy-8-(2hydroxyacetyl)-1-methoxy-9,10-dihydro-7H-tetracene-5,12-dione) is an anthracycline anticancer agent used to treat node-positive breast cancer, ovarian cancer, gastric cancer, lung cancer, and lymphomas (Neil,2006). Streptomyces peucetius strains produce epirubicin through chemical transformation. It interferes with DNA and RNA production by creating a compound and intercalating into nucleotide base pairs. It is preferred over doxorubicin due to its lower toxicity at equimolar dose. This may be due to the opposite chirality caused by the hydroxyl group at the 4' carbon of the sugar moiety, resulting in faster elimination and less toxicity. Docetaxel is a toxoid medication with anti-cancer effects. The semi-synthetic procedure begins with a precursor derived from regenerated yew needles. Docetaxel is available in two forms: anhydrous and trihydrate. Aventis Pharmaceuticals developed Docetaxel, popularly known as Taxotere, to treat a specific kind of cancer. The medication is currently authorised in 90 nations for treating advanced lung cancer and 70 countries for treating advanced non-small cell lung cancer.

Invisible Yet Impactful; Living with Fields Syndrome

Kommala pravallika — 2025-10-25

Fields syndrome is an extremely rare neuromuscular disorder, first reported in 1996, characterized by the combination of muscle weakness (neuromuscular abnormalities) and speech impairment (dysarthria). To date, only two known cases twin sisters from Wales have been documented in medical literature, making it one of the rarest syndromes ever identified. The precise etiology remains unknown, though the familial occurrence in twins suggests a potential genetic basis. However, due to the absence of further reported cases and limited genetic studies, no definitive causative gene or chromosomal abnormality has been identified. Clinically, Fields syndrome manifests as progressive neuromuscular decline, difficulty in movement, fatigue, and impaired coordination, often accompanied by speech difficulties.
Unlike other neuromuscular disorders such as muscular dystrophy, the syndrome is not associated with intellectual disability, which helps in its clinical differentiation. Diagnosis is primarily based on symptomatology and exclusion of other neuromuscular and metabolic conditions, given the absence of specific biomarkers or confirmatory tests. urrently, no targeted treatment
exists for Fields syndrome. Management is largely supportive, including physiotherapy, occupational therapy, and speech therapy, aiming to improve quality of life and maintain functional independence. The scarcity of cases poses a significant challenge for research, limiting insights into its genetic mechanisms and pathophysiology. Further documentation of new cases and
advancements in genomic studies are essential to establish a clearer understanding of the disorder. Fields syndrome represents a unique challenge to clinicians and researchers due to its extreme rarity, uncertain etiology, and lack of targeted therapies. Continued awareness, case reporting, and genetic research are critical for future progress.

A Review on Pears of Nutrition Vs Shadows of Enterocytozoon Hepatopenaei

Shaik Shabna — 2025-10-25

Shrimp aquaculture is a rapidly expanding sector that plays a vital role
in global seafood production and trade. However, the industry faces
significant challenges from emerging pathogens, among which
Enterocytozoon hepatopenaei has gained increasing attention. EHP is a
microsporidian parasite that infects the hepatopancreas of farmed shrimp,
particularly Penaeus vannamei and Penaeus monodon. Unlike other
pathogens that cause acute mortality, EHP does not directly kill shrimp but
severely impairs growth, leading to stunted populations, increased production
costs, and reduced farm profitability. The parasite spreads rapidly through
contaminated broodstock, feed, and pond environments, making its control
extremely difficult. Conventional disease management strategies, including
antibiotics and chemotherapeutics, are ineffective against EHP. Early
detection methods such as PCR and histopathology are critical for farm-level
surveillance and biosecurity. Preventive strategies focus on strict hatchery
screening, biosecure farming practices, and pond management to minimize
horizontal transmission. As EHP infections often occur in combination with
other opportunistic pathogens, they further exacerbate production losses and
threaten the sustainability of shrimp aquaculture. Given its “silent” yet severe
economic impacts, urgent attention is required to enhance farmer awareness,
strengthen diagnostic capacity, and develop sustainable management
strategies. A comprehensive approach involving improved biosecurity,
breeding programs for resistant strains, and international cooperation will be
essential to mitigate the long-term threat posed by EHP in global shrimp
farming.

Recent Trends in Analytical Detection of Impurities in the Drug Substances

Kommala Pavithra — 2025-10-24

Impurity profiling is a critical aspect of pharmaceutical quality
control, as even trace-level contaminants can impact drug safety, efficacy, and
regulatory compliance. The stringent requirements of ICH guidelines (Q3A
Q3D, M7, Q3D) have driven the development of advanced analytical methods
capable of detecting, quantifying, and structurally characterizing impurities at
sub-ppb levels. Recent technological advancements including high-resolution
mass spectrometry (HRMS), multidimensional chromatography (2D-LC), and
hyphenated techniques such as LC–MS/NMR and LC–IMS–MS have
substantially improved sensitivity, selectivity, and structural elucidation
capabilities. Complementary innovations in ambient ionization methods
(DESI, DART, paper spray), process analytical technology (PAT) sensors, and
chemometric and AI-based data analytics now allow high-throughput impurity
screening, real-time process monitoring, and predictive profiling. These
integrated approaches facilitate risk-based impurity management, rapid
detection of genotoxic and trace-level impurities, and enhanced compliance
with regulatory expectations. Furthermore, the development of universal
spectral libraries, standardized data frameworks, and automated analytical
workflows promises to streamline method development, cross-laboratory
reproducibility, and regulatory submissions. This review summarizes the
recent trends in pharmaceutical impurity analysis, highlighting the
convergence of advanced instrumentation, data-driven modeling, and
regulatory-aligned strategies, and emphasizes how these innovations are
transforming impurity detection, characterization, and control. The adoption
of such integrated approaches is expected to improve patient safety, optimize
manufacturing efficiency, and enable predictive quality assurance, positioning
impurity profiling as a cornerstone of modern pharmaceutical development.

Sensitive Gas Chromatographic Method for Monitoring Ethylene Glycol and Diethylene Glycol Contamination in Pharmaceutical-Grade Sorbitol

Nataraj Palaniyappan — 2025-12-04

Ethylene Glycol (EG) and Diethylene Glycol (DEG) are toxic glycol contaminants that pose a significant safety risk when present in pharmaceutical excipients such as sorbitol solution. Several global poisoning incidents linked to EG and DEG contamination have emphasized the need for rigorous monitoring and precise analytical determination of these impurities. Sorbitol solution, widely used as a sweetener and humectant in oral liquid formulations, must therefore comply with stringent regulatory limits established by pharmacopoeias and international health authorities. The present study focuses on the development and evaluation of a sensitive and robust Gas Chromatography (GC) method with Flame Ionization Detection (FID) for the accurate quantification of EG and DEG in sorbitol solution. The method employs 2,2,2-trichloroethanol as an internal standard and optimized chromatographic conditions to achieve reliable separation and quantification. System suitability parameters such as %RSD, retention time consistency, and peak tailing were evaluated to ensure method reliability. The method demonstrated excellent sensitivity, with low LOD and LOQ values for both analytes, ensuring the ability to detect contamination even at trace levels. Sample preparation procedures were standardized to minimize matrix interference and enhance method precision. Overall, the validated GC-FID method proved effective for routine quality control testing, supporting compliance with pharmacopeial specifications and safeguarding the quality of sorbitol-containing pharmaceutical products. This analytical approach strengthens the quality assurance framework and contributes to preventing toxic glycol contamination in pharmaceutical excipients.

Headspace GC-FID Based Estimation of Ethanol content in Indomethacin Oral Suspension

Nataraj Palaniyappan — 2025-12-04

Indomethacin oral suspension is a widely used non-steroidal anti-inflammatory drug (NSAID) formulation intended for patients requiring flexible dosing, rapid therapeutic onset, or difficulty swallowing solid dosage forms. The suspension provides enhanced dosing accuracy, especially in pediatric and geriatric populations, and ensures uniform distribution of the drug within the gastrointestinal tract. Indomethacin exerts its pharmacological effect primarily by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, leading to a reduction in prostaglandin synthesis that mediates inflammation, pain, and fever. Due to its high lipophilicity, the drug quickly achieves therapeutic plasma concentrations, offering effective relief in conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and acute gouty arthritis.The formulation contains ethanol as a co-solvent to improve solubility and maintain suspension stability. As ethanol is a volatile organic component, its accurate quantification is essential for product quality, patient safety, and regulatory compliance. Gas Chromatography (GC) with headspace analysis was employed for determining ethanol content in the formulation due to its sensitivity and selectivity. Method validation parameters, including system precision, linearity, method precision, intermediate precision, accuracy, specificity, and robustness, were thoroughly evaluated. The analytical method demonstrated excellent precision, linearity across the tested concentration range, accurate recovery of ethanol, and no interference from placebo or diluents at the retention times of ethanol and isopropyl alcohol. Robustness studies confirmed the reliability of the method under deliberate variations in analytical conditions. Overall, the validated GC method is suitable for routine quality control of ethanol in Indomethacin oral suspension.

Analytical Method Validation for the Determination of Assay of Carbamazepine API by UPLC

Nithyasree — 2025-12-08

A simple, rapid, reliable and precise reversed phase UPLC method has been developed and validated according to the regulatory guidelines for determination of carbamazepine API in bulk, which composed of isocratic mobile phase; Solution-A: 0.5mL of Triethyl amine and 0.5mL of Formic acid to 1000mL of water. Solution-B: 0.25mL of Formic acid to 1000mL of Methanol, with a flow rate of 0.3 ml/min, and column Acquity UPLC HSS CYANO 10cm x 2.1 mm, 1.8 µm, packing L10. The detection was carried out at 230 nm. The study showed that the proposed UPLC method can be used for the assessment of drug purity.

UPLC: It opened an innovative direction for liquid chromatography covering three major areas including speed, sensitivity and resolution of evaluation by means of the use of packing material with particles size less than 2 µm. The device is created to handle very high pressure experienced by the column.

Quality Control & Quality Assurance in Pharmaceuticals: Essentials to Ensure that Products meet the Required Standards for Safety and Efficacy

Kalyani D. Jaware — 2025-12-12

The pharmaceutical industry is renowned for its stringent quality standards, and ensuring medication effectiveness and patient safety. In order to achieve these objectives, quality control and assurance are crucial. Quality assurance and control are components of quality control.

The use of Quality assurance is essential in all It takes experience to manage quality in the industry. of Total Quality Management and Six Sigma, Out of Specifications (OOS), Out of Trend (OOT), and Corrective & Preventive Measures (CAPA) and ICH compliance rules perfectly. The emphasis of quality assurance is fulfilling quality requirements, while quality Assurance aims to provide reassurance that The quality standards are fulfilled. Products and services are not the only focus of management. quality as well as the methods used to attain it. To progress Industrial product and process quality, especially The automotive sector has also embraced them. by the Food and Drug Administration (FDA) of the United States for Drug discovery, development, and manufacturing.