1. | DESIGN AND DEVELOPMENT OF EXTENDED RELEASE TABLET
FORMULATION OF ALOGLIPTIN BENZOATE |
| Koneru Priyanka, K.Sandhya, Avinash Kumar G, E.Manasa |
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In type 2 diabetes mellitus patients, anlogliptin benzoate is a dipeptidyl peptidase-4 (DPP-4) inhibitor that requires
frequent dosing due to its short half-life, leading to problems with adherence. To improve therapeutic efficacy and
compliance with alogliptin benzoate, this study developed and evaluated an extended-release oral dosage form.
Modulating drug release with hydroxypropyl methylcellulose (HPMC) and ethyl cellulose was achieved through direct
compression with various hydrophilic and hydrophobic polymers. Analogliptin benzoate is compatible with the selected
polymers based on preformulation studies. All of the prepared tablets met pharmacopeial standards for physical properties
like hardness, friability, weight variation, and uniformity of drug content. A diffusion-controlled release mechanism was
demonstrated by the optimized formulation, following the Higuchi model over 24 hours. The extended-release oral dosage
form of alogliptin benzoate developed in this study has the potential to enhance patient compliance by reducing dosing
frequency and ensuring consistent therapeutic effects.
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2. | RPHPLC METHOD DEVELOPMENT AND VALIDATION FOR THE
ESTIMATION OF CLOBAZAM AND FORCED DEGRADATION
STUDIES |
| Rachamalli Monika1, Dinakar A2*, Sandhya K3, Manasa E |
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The spectrophotometric method developed for quantifying Clobazam in bulk and finished pharmaceutical preparations is
highly accurate, sensitive, rapid, precise, and economical. Utilizing UV spectrophotometric absorption at 230 nm, the
method demonstrates a low Limit of Detection (LOD) of 0.2158 ?g/ml and a Limit of Quantification (LOQ) of 0.6915
?g/ml, showcasing its ability to detect and quantify low concentrations of Clobazam. A strong linear relationship was
observed between 30-90 ?g/ml with a regression equation of Y = 0.0248x and a correlation coefficient of 0.997, indicating
excellent linearity. Accuracy was validated with mean percentage recovery ranging from 99.50% to 100%. Precision
studies revealed a Relative Standard Deviation (RSD) of 0.42% for intra-day and 0.56% for inter-day measurements,
ensuring consistent results. The method’s robustness was confirmed with RSD values below 2.0% under varied
conditions. Application to Clobazam tablets yielded assay results of 99.97% with RSD values below 2.0%, demonstrating
suitability for routine analysis. Chromatographic parameters showed a capacity factor greater than 2, theoretical plates
numbering 8576, and a tailing factor of 1.27, indicating excellent performance. In degradation studies, Clobazam showed
less than 6.0% decomposition under thermal, oxidative, and UV conditions. Acidic degradation resulted in 7.80%
decomposition, and alkaline conditions produced a major degradant at 2.987 minutes without interfering with the main
drug peak at 3.891 minutes, with a drug decomposition percentage of 2.85%. This method reliably distinguishes between
Clobazam and its degradation products, making it suitable for precise and accurate analysis even under stressed
conditions
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3. | SYNTHESIS CHARACTERIZATION AND PHARMACOLOGICAL
SCREENING OF SOME NOVEL SUBSTITUTED THIOCROMENE
DERIVATIVES AS ANTI-INFLAMMATORY AGENTS |
| Kaneez Fatima Ansari, Deepak Patel*, Reetesh Yadav |
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All the newly synthesized compounds were characterized by their physical properties and spectral data. The purity of
newly synthesized compounds was confirmed by TLC. Spectral analysis (IR, 1H, 13C NMR and Mass spectrometry) of
the compounds adequately supported the structures of the synthesized compounds. The appearance of a band between
1764-1623 cm-1 (C=O) in the IR spectra; a singlet peak at ? value 4.3-5.0 for two protons of CH2 of the
pyrazolidinedione ring in the 1H NMR spectra and a peak at ? 41.7-46.9 for carbon of CH2 of the pyrazolidinedione ring
supports the formation of pyrazolidinedione substituted thiochromene derivatives (20-35). Molecular ion peaks of the
synthesized pyrazolidinedione substituted thiochromene derivatives were obtained on the mass spectra, corresponds with
their structures. These spectral data satisfactorily supports the formation of the title compounds.
The formation of thiochromene and pyrazolidinedione moieties is supported by the reaction mechanism.
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