STABILITY-INDICATING HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF FORMOTEROL FUMARATE DIHYDRATE AND FLUTICASONE PROPIONATE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

Objective: The objective of the present work was to develop validated stability-indicating high-performance thin-layer chromatographic method for simultaneous estimation of formoterol fumarate dihydrate (FFD) and fluticasone propionate (FP) in bulk drug and pharmaceutical dosage form. Methods: Pre-coated silica gel aluminum plates 60 F-254 were used as stationary phase. The mixture of toluene:ethyl acetate:formic acid (98%) (6:4:0.1; v/v/v) was used as a mobile phase. The densitometric quantification was carried out at 233 nm. The method was validated according to the ICH guidelines. The specificity and stability indicating the capability of the method were proven though degradation studies. Both drugs were subjected to acid (0.1N HCl) and base (0.1N NaOH) hydrolysis, oxidation (3% v/v H2O2), photolytic, and neutral degradation conditions. Results: The selected mobile phase resolved peaks of FFD and FP with Rf values 0.27±0.10 and 0.64±0.10, respectively. Determination coefficients of calibration curves were found to be 0.998 and 0.999 in the range of 1–3.5 μg/spot and 10–60 μg/spot for FFD and FP with an accuracy of 99.09% for FFD and 99.20% for FP. The degradation products of FFD and FP were resolved from the pure drug with significant differences in their retention factor values. Conclusion: The developed method is simple, accurate and can be successfully applied for quantification of FFD and FP in bulk drug and pharmaceutical dosage form, contributing to improve the quality control and assure the therapeutic efficacy

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF VOGLIBOSE IN PHARMACEUTICAL DOSAGE FORMS

Objective: This paper describes a new, simple, precise, accurate and specific HPTLC method for estimation of voglibose as a bulk drug and in tablet dosage forms.Methods: Chromatographic separation of the drug was performed on aluminum plates pre-coated with silica gel 60 F254 as the stationary phase and a mobile phase comprising of toluene: ethyl acetate: methanol: 30% ammonia 5:4:1.5:0.2 (v/v/v/v). Densitometric quantification of voglibose was carried out at 292 nm. Voglibose was detected satisfactorily with a Rf value 0.26.Results: The accuracy and reliability of the method was assessed by evaluation of linearity (0.2-1.2 µg/spot), precision (intra-day RSD 0.6-0.9% and inter-day RSD 0.20-0.25%), accuracy (97.32-102.46%) and specificity according to ICH guidelines. Conclusion: The proposed HPTLC method is less expensive, simpler, rapid and more flexible than the reported RP-HPLC method for routine analysis of voglibose in bulk and tablet dosage forms.Â

Development and validation of a HPTLC method for Estimation of Duloxetine Hydrochloride in Bulk Drug and in Tablet Dosage Form

Duloxetine hydrochloride is a potent dual reuptake inhibitor of serotonin and norepinephrine used to treat major depressive disorders. The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. The chromatographic separation was carried out on precoated silica gel 60 F254 aluminium plates using mixture of chloroform:methanol (8:1 v/v) as mobile phase and densitometric evaluation of spots was carried out at 235 nm using Camag TLC Scanner-3 with win CAT 1.3.4 version software. The experimental parameters like band size of the spot applied, chamber saturation time, solvent front migration, slit width etc. were critically studied and optimum conditions were evolved. The drug was satisfactorily resolved with Rf value 0.11±0.01. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (40-200 ng/spot), precision (intra-day RSD 0.46-0.75%, inter-day RSD 0.46-1.59%), accuracy (98.72±0.20) and specificity according to ICH guidelines. The proposed method can analyse ten or more formulation units simultaneously on a single plate and provides a faster and cost-effective quality control tool for routine analysis of duloxetine hydrochloride as bulk drug and in tablet formulation

RNA Interference: A revolution in drug development

316-322RNA interference (RNAi) or gene silencing technology is a phenomenon by which double stranded RNAs elicit degradation of a target mRNA containing homologous sequence. It is essentially a new incarnation of well-established antisense principle. This technology enables the researchers to trigger post-transcriptional gene silencing in vivo. It is a robust method for lowering specific protein levels, compared to traditional techniques such as antisense, ribozymes or microinjection of function-blocking antibodies. RNAi offers a powerful tool for ascribing functions to genes while its application to in vivo models of disease opens up tremendous opportunities to develop a novel generation of oligonucleotide-based drugs, thus offering an enormous potential of being developed as a therapeutic modality