1. | ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR
SIMULTANEOUS ESTIMATION OF SALMETEROL AND FLUTICASONE
PROPIONATE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RPHPLC METHOD |
| Srilatha S, Rajitha S |
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A new method was established for simultaneous estimation of Salmeterol and Fluticasone propionate by RP-HPLC method.
The chromatographic conditions were successfully developed for the separation of Salmeterol and Fluticasone propionate by
using Zodiac sil C18 column (4.6×150mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol:
phosphate buffer (KH2PO4and K2HPO4) phosphate pH 3 (pH was adjusted with orthophosphoricacid), detection wavelength
was 240nm. The instrument used was Shimadzu, model No. SPD-20MA LC+20AD, Software- LC-20 Solution. The retention
times were found to be 2.170 mins and 7.280mins. The % purity of Salmeterol and Fluticasone propionate was found to be
99.1% and 98.2% respectively. The system suitability parameters for Salmeterol and Fluticasone propionate such as
theoretical plates and tailing factor were found to be 12294, 1.27 and 10491 and 1.03, the resolution was found to be 8.67.
The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Salmeterol and
Fluticasone propionate was found in concentration range of 16µg-80µg and 25µg-125µg and correlation coefficient (r2) was
found to be 0.999 and 0.998, % recovery was found to be 101.7% and 102.0%, %RSD for repeatability was 0.8and 0.5, %
RSD for intermediate precision was 1.99 and 1.82 respectively. The precision study was precision, robustness and
repeatabilty.LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively
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2. | FORMULATION, DEVELOPMENT AND EVALUATION OF OCULAR
IN SITU GEL OF NSAIDS DRUG |
| Naveen Maurya*, Surendra Pratap Singh, Jitendra Kumar Malik, Sonam Baghel |
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The aim of this study was to prepare and evaluate a pH sensitive ocular in-situ gel of Nepafenac, to increase the
ocular residence time. Methods: pH sensitive in situ gel formulations were prepared using different concentrations of
Carbomer CB [0.5%, 0.6%, 0.7%] in combination with hydroxypropyl methylcellulose HPMC K40 [0.75%, 1%, 1.5%] or
HPMC K100 [0.5%, 0.75%, 1%, 1.5%]. The prepared in situ gels were evaluated for appearance, pH, gelling capacity
[sol-to-gel transition/in vitro], tonicity, viscosity, in vitro release studies, release kinetic analysis, and the selected
formulas were subjected to rheological studies, and the finally selected formula was subjected to drug content, FT-IR
studies, and ocular irritancy tests. Results: Increasing the concentration of the carbomer polymer improved the gelling
capacity and gelation time, also the higher the viscosity and concentration of the hydrophilic HPMC polymer, the higher
the viscosity of the formula, which affected the release, gelation capacity and time. The overall results showed that
formula F10 [CB 0.7%, HPMC K100 0.75%] exhibited excellent pH-triggered in-situ gelation time, sustained the release
of Nepafenac for 3 h’ time with a release rate of more than 90%. Conclusion: Ocular in situ gel of Nepafenac offers a
potential dosage form to increase the residence time in the ocular cul de sac, decreasing the drug drainage, and increasing
the effectiveness of the drug
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3. | DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR
COMBINED ANALYSIS OF METRONIDAZOLE AND OFLOXACIN |
| Rajitha S1*, Navya Sri M2, Slagya K2, Vandana G2, Jafreen SK2, Durga Bhavani G |
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A combination drug most commonly refers to a fixed-dose combination (FDC), which is a formulation including two or
more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed
in certain respective fixed doses. Analytical chemistry is the study of the separation, identification, and quantification of
the chemical components of natural and artificial materials. Qualitative analysis is performed to establish composition of
natural/synthetic substances. These tests are performed to indicate whether the substance or compound is present in the
sample or not. Quantitative analytical techniques are mainly used to quantify any compound or substance in the sample.
Metronidazole works by entering the bacterial or protozoal cell and disrupting its DNA synthesis. Ofloxacin acts on DNA
gyrase and Toposiomerase IV, enzymes which, like human Topoisomerase, prevents the excessive super coiling of DNA
during replication or transcription. A simple, accurate, precise method was developed for the simultaneous estimation of
the Metronidazole and Ofloxacin in pharmaceutical dosage form HPLC method can be used for routine drug analysis of
Metronidazole and Ofloxacin in pharmaceutical dosage form
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4. | GELATIN BASED IN SITU GELS: A NOVEL APPROACH FOR
ENHANCED GANCICLOVIR DELIVERY AND IN VITRO
EVALUATION |
| Asha Jyothi P, Pavan P, Revanth Kumar K, Swachiitha N, Keerthi Chavala K, Jhansi K |
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This study aimed to develop and evaluate HPMC-gelatin-based in situ gels for enhanced delivery of Ganciclovir, an antiviral
drug commonly used in the treatment of cytomegalovirus (CMV) infections. The formulation strategy focuses on improving
the drug's bioavailability and therapeutic efficacy by utilizing in situ gelling systems that provide sustained release and
targeted delivery. Hydroxypropyl methylcellulose (HPMC) and gelatin were selected as the primary polymers due to their
biocompatibility, gel-forming properties, and ability to enhance drug stability. The in situ gels were prepared by dissolving
Ganciclovir in an aqueous solution containing HPMC and gelatin. The formulation parameters, including polymer
concentration, pH, and temperature sensitivity, were optimized to ensure appropriate gelation and drug release characteristics.
The developed in situ gels were characterized for gelation temperature, viscosity, drug content, and in vitro drug release. The
optimized formulation exhibited a gelation temperature of 37°C, suitable for in vivo applications. The viscosity
measurements indicated a manageable flow at room temperature and rapid gelation at body temperature. Drug content
analysis confirmed uniform distribution of Ganciclovir within the gel matrix. The in situ gels also showed good
mucoadhesive properties, enhancing the retention time at the site of application. Cytotoxicity assays on fibroblast cell lines
indicated that the HPMC-gelatin gels were non-toxic and biocompatible. Furthermore, antiviral activity tests confirmed the
enhanced efficacy of Ganciclovir delivered via the in situ gel system
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5. | DESIGN, DEVELOPMENT AND EVALUATION OF POSACONAZOLE
BUCCAL PATCHES FOR ENHANCED RELEASE USING NATURAL
POLYMERS |
| GONJI AKHILA, MANASA E, AVINASH KUMAR G, SANDHYA K |
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It has been demonstrated that buccal patches are an effective method of delivering drugs locally as well as systemically.
This study examines the use of natural polymers in the formulation of oral patches containing posaconazole. As natural
polymers, Xanthan Gum and Guar Gum were used to prepare the patches. In order to characterize the formulations, the
physical appearance, thickness, weight variation, flatness, moisture uptake, swelling study, and the in vitro drug release
profiles were assessed. Posaconazole is compatible with the polymers used in this study according to FTIR spectroscopy.
Furthermore, the patches demonstrated good mucoadhesive properties, suggesting that the patches would remain at the
application site for a longer period of time and that drug absorption would be enhanced through the buccal mucosa. In
general, natural polymers have been effective in improving the bioavailability and therapeutic efficacy of posaconazole
buccal patches. A major contribution of this research is the development of innovative drug delivery systems utilizing
natural polymers in order to enhance therapeutic outcomes in antifungal therapy
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