1. | NOVEL METHOD DEVELOPMENT AND VALIDATION FOR THE
ASSAY OF BIVALIRUDIN HYDROCHLORIDE USING LIQUID
CHROMATOGRAPHY |
| Nerupaka Maheswari, Sandhya K, Dinakar A, Avinash Kumar G |
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A liquid chromatographic method for the determination of bivalirudin in bulk and finished pharmaceutical dosage forms has
been developed and validated. This method is characterized by its selectivity, accuracy, precision, and linearity over the
studied concentration range. The calibration curve exhibited a linear relationship between concentrations of 2-20 ?g/ml, with
a limit of detection (LOD) of 0.5792 ?g/ml and a limit of quantification (LOQ) of 1.775 ?g/ml. The method’s accuracy was
confirmed by a mean percentage recovery of 100.7%, and precision was evidenced by repeatability and intra- and inter-day
variations with a relative standard deviation (RSD) of less than one percent. The validated method is suitable for quality
control and routine analysis of bivalirudin in both bulk and finished dosage forms, ensuring consistent quality and efficacy in
pharmaceutical products
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2. | DEVELOPMENT OF RPHPLC METHOD FOR SIMULTANEOUS
ESTIMATION OF EMPAGLIFLOZIN, METFORMIN AND
LINAGLIPTIN |
| Nennuru Supraja1, Dinakar A2*, Sandhya K2, Manasa E |
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A novel RP-HPLC method was developed and validated for the simultaneous estimation of Metformin, Linagliptin, and
Empagliflozin in pharmaceutical dosage forms. This method is designed to handle a high throughput of samples efficiently,
offering robustness, accuracy, and precision without requiring prior separation steps. The choice of methanol and potassium
dihydrogen orthophosphate as the mobile phase allowed for effective solubility and separation of the analytes. The method's
run time was optimized to 5 minutes, facilitating rapid analysis. Validation parameters, including system suitability, linearity,
precision, accuracy, specificity, ruggedness, robustness, LOD, and LOQ, were thoroughly assessed. System suitability
parameters were within acceptable limits, confirming the system's reliability. Linearity was observed within the 10-100
?g/mL concentration range, with percentage recoveries for Metformin, Linagliptin, and Empagliflozin ranging from 98.22%
to 99.25%. No interference from excipients or the mobile phase was detected, ensuring specificity. The method demonstrated
robustness and ruggedness through consistent results despite variations in flow rate, mobile phase composition, and different
analysts conducting the analysis. This validated RP-HPLC method is rapid, accurate, and efficient, making it highly suitable
for routine analysis and quality control in pharmaceutical laboratories.
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3. | ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR
THE SIMULTANEOUS ESTIMATION OF METFORMIN
HYDROCHLORIDE AND ROSIGLITAZONE BY RP-HPLC IN BULK
AND TABLET DOSAGE FORMS |
| Rajkumar Mishra1, Ketkee Mandawar1*, Nishi Prakash Jain1 |
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Objective: The day by day new combinations drugs are being introduced in market. Then the multiple therapeutic agents
which acts at different sites are used in the management of various diseases and disorders are done. Thus it is necessary to
develop methods for analysis with the help of number of analytical techniques which are available for the estimation of
the drugs in combinations. An accurate, precise and reproducible RP-HPLC method was developed for the simultaneous
quantitative determination of Metformin Hydrochloride (MET) and Rosiglitazone (NTG) in tablet dosage forms. Methods:
Younglin (S. K.) gradient system UV detector and C18 column with 250 mm x 4.6 mm i. d. and 5?m particle size
Acetonitrile : OPA water (80 : 20v/v) pH 2.5 was used as the mobile phase for the method. The detection wavelength was
283 nm and flow rate was 0.9 ml/min. Results: In the developed method, the retention time of MET and NTG were found to
be 6.366 min and 8.616 min. The developed method was validated according to the ICH guidelines. Conclusion: In this
methods linearity, precision, range, robustness were observed. The method was found to be simple, accurate, precise,
economic and reproducible. So the proposed methods can be used for the routine quality control analysis of MET and NTG
in bulk drug as well as in formulations.
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4. | STABILITY INDICATING HPLC ASSAY METHOD
DEVELOPMENT FOR DETERMINATION OF OLANZEPINE |
| Abhay Kumar*, Ketkee Mandawar, Seema Sahu, Dr. Nishi Prakash Jain |
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A simple, precise and specific reverse phase high performance liquid chromatographic method has been developed and
validated for the determination of Olanzepine in tablet. It was found that the excipient in the tablet dosage forms does not
interfere in the quantification of active drug by proposed method. The HPLC separation was carried out by reverse phase
chromatography on The Agilent HPLC 1200 series, with Open Lab software, PDA and VWD detector were used for
quantitative estimation of OLZ. Stationary phase consisted of Xterra RP C18 (150 x 4.6mm, 5?m), SPD–10 UV detector and
LC 10 ADVP Pumps. Auto-injector with 15 ?l injection volume with a Mobile phase comprised of buffer consisting 0.138 %
w/v of sodium dihydrogen phosphate monohydrate in Ultra pure water (pH was adjusted to 6.8 with NaOH) and Acetonitrile
in the ratio 50:50 at flow rate 1.0 mL/min. The detection was monitored at 270 nm. The calibration curve for Olanzepine e
was linear from 25-150 ?g/mL. The inter-day and intra-day precision was found to be within limits. Accuracy (recoveries:
99.8-103.2%) and reproducibility were found to satisfactory. The method was found to be specific against excipients
interference and stress condition. Stress testing showed degradation product and impurity were well-separated from the
parent compound, conforming stability-indicating capacity of the method
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5. | OPTIMIZING PHARMA INDUSTRY FIRE HAZARDS:
BALANCING, SAFETY, EFFICACY AND INNOVATION |
| Albin K Alex, Stephy Anna Saji1, Linta Titus, Aleena Merin Abraham1,
Krishnarajan D |
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Any actions, materials, or conditions that might increase the size or severity of a fire or that might cause a fire to start are
called fire hazards. This topic outlines the fundamental principles of fire science, including the fire triangle concept, and
explores various types of fire hazards such as electrical issues, smoking, human error, combustible dust, arson, heating
equipment malfunctions, mechanical friction, flammable substances, and employee negligence. This content emphasizes
critical fire prevention strategies, including regular electrical system maintenance, proper smoking material disposal,
employee training, dust control measures, security protocols, equipment maintenance, safe handling of flammable materials,
and encouraging hazard reporting. It also discusses different classes of fires (A, B, C, D, and K) and various types of fire
extinguishers (dry chemicals, CO2, wet chemicals, and foam). This content underscores the importance of implementing
comprehensive fire safety programs, conducting regular inspections, maintaining equipment properly, and establishing clear
safety protocols. This information provides a foundation for developing effective fire prevention and response strategies in
workplace settings, ultimately contributing to enhanced occupational safety and reduced fire risks
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6. | SYNTHESIS, CHARACTERIZATION AND EVALUATION OF 2, 4-
THIAZOLIDINE-2, 4-DIONES NOVEL ANALOGUES FOR
ANTICANCER POTENTIAL |
| Dholariya Harshkumar*, Sandeep Patel, Nishi Prakash Jain |
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Compounds with halogen group substitution on aromatic ring exhibited promising activity. Compound 3i with the 2,3-
dichloro group at the phenyl ring attached to heterocyclic thiazolidine-2,4-dione showed potent activity against HeLa cells
when compared with reference drug adriamycin. Substitution at R with electron withdrawing groups such as chloro, bromo,
iodo in compounds 3a, 3b, 3f, 3g and 3i showed increase in activity. The electron donating groups such as methoxy, ethoxy,
methyl, ethyl and hydroxy substituted compounds 3c, 3e, 3j, 3l, 3m, 3o, 3p, 3r showed decrease in activity. The compound 3i
with 2, 3-dichloro substitution on the phenyl ring exhibited IC50 value of 0.007 ?M better than other substitutions.
Compounds 3n with 3-NO2 groups showed significant improvement in activity. Compound 3h with 3-CN group substitution
on the phenyl ring exhibited intermediate potency in the series. Constitutively, 3j and 3k containing 3-hydroxy and 3,4-di
hydroxy groups attached to phenyl ring showed decrease in activity compared to other derivatives of the series, attributed to
the presence electron withdrawing group decrease the potency. Here compound 3i which consist halogen group substitution
on aromatic ring showed potent activity against HCT-8 cells when compared with reference drug adriamycin. Substitution at
R with electron withdrawing groups such as 4-Cl, 3-Br, 4-Br and 2,3di-Cl (0.097, 0.056, 0.012, 0.011 ?M, consecutively).
Substitution at R with electron donating groups such as -4OCH3, 2, 5 di OCH3, 4C6H5O-, 3-OH, 3,4-di-OH, 4-Me, 3,4di
Me, 4-NH2 and -4OC2H5 were showed decreased in activity against HCT-8 cells.
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