Objective: The objective of this research was to develop a simple, precise, accurate, and stability-indicating reverse-phase high-performance liquid chromatographic method for estimation of azelastine hydrochloride (AZL) in nasal spray preparation. Methods:Chromatography was performed on a 250 mm×4.6 mm, 5-μm particle size, Waters Spherisorb CN column using (50:50 v/v) mixture of potassium dihydrogen phosphate buffer and acetonitrile as mobile phase. The detection was carried out at 290 nm and flow rate employed was 1.0 ml/min. The degradation of AZL was studied under different ICH recommended stress conditions. Results:The retention time was 4.34 min for AZL. Linearity was established in the concentration range of 5-120 µg/ml, with a correlation coefficient of 0.9996. Limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.81 µg/ml and 2.44 µg/ml, respectively. Percentage recovery was found between 99 and 102%. The values of percentage relative standard deviation (<2%) proved the high precision of the proposed method. The method was found to be robust regarding any small variation in the column temperature, pH of mobile phase, and mobile phase ratio. AZL was found stable in 5 M HCl at 80°C for 5 h, 5 M NaOH at 80°C for 5 h, 30% H 2 O 2 at 80°C for 5 h, and in oven at 70°C for 8 h. Conclusion:The results obtained in this research work clearly proved that the proposed HPLC method for the assay of AZL in nasal spray preparation is simple, precise, specific, accurate, and stability indicating. It indicates that the method is suitable for analysis of AZL in the raw material and the pharmaceutical product without interference from excipients.
A simple, precise, rapid and accurate UFLC method has been developed with due validation for the simultaneous estimation of Amlodipine besylate and Celecoxib in rat plasma. The separation has been taken place by C18 Eclipse plus column at 1ml/min flow rate. The mobile phase comprises of 20 mM sodium acetate buffer of pH 4.5 adjusted with glacial acetic acid and methanol (30:70% v/v). The effluents were monitored at 228 nm with a total run time of 15min. The retention time of Amlodipine besylate and celecoxib were found to be 7.69 min and 10.69 min respectively. The extraction of drugs have been achieved by protein precipitation technique with methanol as a solvent. The detection concentration was linear over 60–420 ng/ml for Amlodipine besylate and 600-4200 ng/ml for Celecoxib. Regression equation of Amlodipine besylate and Celecoxib were found to be y = 30.996x + 520.29 & y = 39.722x + 23706 with regression coefficient 0.9944 & 0.9941 respectively using unweighted and weighted linear regression with a weighting factor of 1/x0, 1/x, 1/✓x and 1/x2. The percentage recoveries were found to be 88.52±1.276 to 93.06±2.872 for Amlodipine & 89.40±0.728 to 94.05±0.221 for Celecoxib. This liquid chromatography method was extensively validated for linearity, accuracy precision, and stability studies.
Simultaneous quantification of Lopinavir and Ritonavir in tablet by HPTLC method was developed and validated. The chromatograms were developed using a mobile phase of Chloroform: 1, 4 -Dioxane (7:3 %v/v) on pre-coated plate of silica gel GF aluminum TLC plate and quantified by densitometric absorbance mode at 210 nm. The R f value for lopinavir and ritonavir was 0.74 and 0.58 respectively. The linearity of the method was found to be within the concentration range of 160-960 ng/spot for Lopinavir and for Ritonavir, it was 40-240 ng/spot. The lower limits of detection and quantification were 9.56 ng/spot and 28.96 ng/spot for Lopinavir and 6.82 ng/spot and 20.66 ng/spot for Ritonavir. The method was also validated for precision, specificity and recovery. This developed method was used to analyze fixed-dose tablet (Lopimune, Cipla Ltd) sample of Lopinavir and Ritonavir.
The objective of this study is to screening of suitable non volatile liquid vehicle for the formulation of liquisolid tablets such as propylene glycol, polyethylene glycol 400 and tween 80 by using mathematical equations for enhancement of dissolution rate of drug and comparison of liquisolid technique with inclusion complex of β-cyclodextrin. Different liquisolid compacts were prepared using a mathematical model for calculating required quantities of powder and liquid ingredients to produce an acceptably flow able and compressible admixture. The prepared liquisolid systems were evaluated for their pre compression and post compression parameters. The drug-excipient interactions studies carried out by Infrared spectroscopy (IR) and X-ray diffraction (XRD). The maximum solubility of valsartan was found to be in propylene glycol. The liquisolid formulations containing propylene glycol as a non volatile solvent showed higher drug release. The IR studies confirmed that there was no interaction between the drug and excipients. The XRD analysis confirmed formation of a solid solution inside the compact matrix. All the pre compression and post compression properties of the liquisolid compacts were within the acceptable limits. Liquisolid technique can be used to improve the dissolution rate and bioavailability of low soluble drugs.
Objective: The present study gives a simple, rapid, and accurate stability indicating reverse phase high-performance liquid chromatography method for the determination of loxapine succinate and its related substance (related compound A) in capsule dosage form. Methods: Loxapine succinate and its related substance were attained on a C18 Purospher star (250 mm × 4.6 mm, 5 μm particle size) column at 254 nm detection wavelength, 1.0 ml/min as a flow rate, and 10 μl injection volume. Water:methanol: Triethylamine: Tetrahydrofuran (50:40:1:10) was used a mobile phase, and column oven temperature was 30°C. Results: The resolution between loxapine succinate and known unknown impurities was >2.0. The correlation coefficient (0.999) value indicates the linear relationship between the concentration and peak areas. The accuracy study was performed by spiking method. Loxapine succinate was exposed to the stress condition of hydrolysis (acid and base), oxidative, thermal, and photolytic degradation. Loxapine succinate was found to degrade unquestionably in acid and base stress condition and almost stable in oxidative, thermal, and photolytic conditions. Conclusion: The degradant products were well resolved from leading peak and its related compound A peak and any other unknown peak justifying the stability indicating capability of the method. The developed method was validated as per the ICH guidelines. This method is used for periodic analysis in laboratory.
Numerous bioactive heterocyclic products containing carbazole nucleus showed pharmacological and biological significance. Carbazole have been found in several of significant drug like fragments which provided a precious indication for action and in emerging new valuable derivatives. Carbazole possess several biological activities, i.e., action against viral infection, inflammation, cancer, HIV, microbial infection, tubercular infection, diabetes mellitus, malarial parasite infection, cholinesterase related disorders, etc. which made attention among research scholars to produce variety of carbazole molecules. This review revealed that carbazole molecules have different pharmacological actions and have a vast possible to be discovered for therapeutic potentials.
The purpose of the study is to formulate Fexofenadine hydrochloride complex with inclusion complex with β-Cyclodextrin, because Fexofenadine hydrochloride having a poorly solubility and bioavailability. Inclusion complex with β-Cyclodextrin improve the characteristic and dissolution rate as compare to marketed product. Fexofenadine hydrochloride is an antihistaminic agent used for treatment of relieving hay fever and allergy symptoms, such as sneezing and red, itchy, tearing eyes. Its poor solubility is major problem for the patient compliance. Cyclodextrin have ability to molecularly encapsulate wide variety of drugs into their hydrophobic cavity without formation of any covalent bonds. Cyclodextrin (CDs), especially β-Cyclodextrin (β-CD), are widely used in the pharmaceutical field owing to their ability to stabilize drug molecules as well as for taste masking purpose. Phase solubility study records shown that the stability constant and complex stoichiometry of Fexofenadine β-CD complexes gives linearly improve with the concentration of β-CD, beside Fexofenadine-HP β-CD complexes does not shows more change in solubility curve. Hence β-CD was chosen to prepare inclusion complexes. Inclusion complexes with β-CD were prepared by physical mixture, kneading method and Co-precipitation method. Complexes were analyzed by UV-VIS spectroscopy and were characterized by infrared spectroscopy, thermal analysis, XRPD. Within 30 min, more than 90 % drug was released from the complexes, were good as compare to marketed product which shown in release profile.
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