International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Fabrication and Solid State Characterization of Ticagrelor Co-Crystals with Improved Solubility and Dissolution
Nazare Lobo John Shane, Ashish Hanumantrao Chamle, Vasantharaju, Aravind pai, Girish Pai, Muddukrishna Badamane Sathyanarayana
In the present study a new co-crystal of Ticagrelor with L-Tartaric acid has been prepared with improved solubility. Ticagrelor is a class VI drug with poor solubility and permeability; hence an attempt has been made to improve its solubility by co-crystallization technology.A co-crystal is a structurally homogeneous crystalline material containing an API and the co-former in definite stoichiometric amounts. In this study the conformer selected was L-Tartaric acid based on ease of hydrogen bond formation. The co-crystal of Ticagrelor with L-Tartaric acid was prepared in different ratios (1:1, 2:1, 1:2). Ticagrelor formed stable co-crystals in the ratios 1:1&2:1. The formation of co-crystal was confirmed by FTIR, DSC and PXRD. The dynamic solubility of co-crystals in the ratios 1:1 and 2:1 was increased by approximately 2.7 and 2.6 fold respectively as compared to pure drug. The in-vitrodissolution study demonstrated a 1.5 fold increase in the solubility for selected TIC:L-TAR (1:1) as compared to its TIC active pharmaceutical ingredient and TIC physical mixture.

2. New RP-HPLC Method Development and Validation for the Determination of Pazopanib Hydrochloride in Tablet Dosage Form
Rajesh Babu Y, Appala Raju N
The aim of this paper was to develop and validate the stability indicating RP-HPLC method for the determination of Pazopanib hydrochloride in bulk and pharmaceutical dosage forms. A simple, accurate, precise, sensitive and stability indicating RP-HPLC method has been developed for the determination of Pazopanib hydrochloride in bulk drug and pharmaceutical dosage form, in which separations are done using develosil C18, 5μm, 150 × 4.6mm i.d. column at a flow rate of 1.0mL/min with an injection volume of 20μL. The beer’s law was obeyed over the concentration range of 5 – 35μg/mL. The correlation coefficient was found to be 0.996 and it showed good linearity, reproducibility, precision in this concentration range. The % recovery values were found to be within the limits, which showed that the method was accurate. The LOD and LOQ were calculated using statistical methods. The % RSD values were less than 2. The developed method was successfully applied for determination of Pazopanib hydrochloride in pharmaceutical dosage form. The results obtained are in good agreement with those obtained by using the standard method.

3. Simultaneous Spectrophotometric Determination of Salbutamol by Coupling with Diazotized 4-Aminobenzoic acid
Hind Hadi, Gufran Salim
A simple, rapid and sensitive spectrophotmetric method for trace determination  of salbutamol (SAL) in aqueous solution and in pharmaceutical preparations is described. The method is based on the diazotization coupling reaction of the intended compound with 4-amino benzoic acid (ABA) in alkaline medium to form an intense orange, water soluble dye that is stable and shows maximum absorption at 410 nm. A graph of absorbance versus concentration  indicates that Beer’s law is obeyed over the concentration range of 0.5-30 ppm, with a molar absorbtivity 3.76×104 depending on the concentration of SAL. The optimum conditions and stability of the colored product have been investigated and the method was applied successfully to the determination of SAL in dosage forms.

4. Development and Validation of LC-MS/MS Method for the Estimation of Lovastatin and its Metabolite (β-Hydroxy Acid) in Pharmaceutical Dosage Form
Hareesh divadari, Vijay Srinivas Pothula
The objective of this study was to validate a simple, specific, accurate and precise Liquid – Liquid extraction high performance liquid chromatographic method with Tandem Mass Spectrometry-Thermo Scientific TSQ Quantum Ultra method for the determination of Lovastatin and Lovastatin acid in human plasma using Atorvastatin as Internal Standard (IS). The precision and accuracy data have to fulfill the requirements for quantification of the analytes in biological matrices to generate data for bioequivalence, bioavailability investigations. A Luna C18, 5µm column having 4.6 x 150 mm internal diameter in isocratic elution mode with flow rate1.0 mL/min of mobile phase containing and Methanol, 5mM ammonium formate in 0.1% formic acid (80:20v/v) were used. The chromatographic separation was achieved by using elution solution consisting of Methanol and 5mM ammonium formate in 0.1% formic acid (80:20%v/v), diluent solution of methanol and water (50:50%,v/v) were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring (MRM) mode. The method was validated for both Lovastatin and Lovastatin acid over the concentration range of 0.05-5.00 ng/mL using 300 µL plasma samples. Limit of quantification was found 0.05 ng/mL. The retention time for Lovastatin acid and Lovastatin min 2.84 and 3.45 respectively and Internal Standard were 2.06 min and overall chromatography run time was 5.50 minutes. The mean recovery of Lovastatin (71.00%) and Lovastatin acid (81.20) and IS (79.84%) from spiked plasma samples was consistent and reproducible. The method was validated for linearity, accuracy, precision, specificity, limit of quantification and robustness. The intra- and inter-day precision and accuracy values were found to be within the assay variability limits as per the FDA guidelines1. The developed assay method was applied to a clinical pharmacokinetic study in human volunteers.

5. Comparative Study for Selection of the Optimum Mobile Phase for Separation of Caffeine and Paracetamol by Using TLC Chromatographic Method
Mohammed Gamal, Ali Turki, Almonzer Al-Shemari, Abd Alla Alomari
Objective.  To investigate the best mobile phase for separation of Paracetamol (PAR) and Caffeine (CAF) using TLC method. Methods.  Different mobile phases which were mentioned in literature review were tried and retention times for both PAR and CAF were recorded for each experiment separately. Results : It was found that retardation factors  for solvent A Rf (PAR) =0,59  and Rf(CAF)=0,90 ; for solvent B Rf(PAR)=0,92  and Rf(CAF)=0,81; Rf(PAR)=0,22 and Rf (CAF)=0,16.  Solvent A is composed of    n-hexane-ethyl acetate-ethanol (2.5 + 1.5 + 0.4, v/v/v), solvent B is composed of  chloroform,ethyl acetate and ammonia (15,0 + 4,3 + 0,3 v/v/v) and solvent C is composed of  methanol,glacial acetic acid and water (25,0 +4,3+70,7 v/v/v ). Conclusion: It was found that the best solvent for separation of CAF and PAR in TLC chromatographic method was composed of n-hexane-ethyl acetate-ethanol (2.5 + 1.5 + 0.4, v/v/v).

6. Development and Validation of Stability Indicating RP-HPLC Method For Estimation of Clofazimine in  Soft Gelatine Capsule
Patel H A, Patel K G, Pathak D S, Patel D J,  Meshram D B
Stability indicating reverse phase high performance liquid chromatography method was developed for the estimation of Clofazimine in bulk drug and soft gelatin capsules. The chromatographic separation was achieved on ODS C18 column using mobile phase comprising 10 mM citrate buffer : acetonitrile, in which pH of buffer is adjusted with 1N HCL solution in ratio of (70:30 v/v), flow rate was 1.0 ml/min and eluents were detected by UV detector at 283 nm. Retention time of Clofazimine was found to be 5.205 min. Linearity range was found over the concentration range 25-75 μg/ml. Clofazimine was subjected to various stress conditions i.e. Acid, Base, Oxidative, Thermal and Photolytic degradation. The degradation peak of formulation of Clofazimine were well resolved from the pure peak. The proposed method were validated according to the ICH guidelines and it can be suitable for quality control analysis of Clofazimine in soft gelatin capsule.

7. Development and Validation of HPTLC Method for Estimation of Cyamemazine Tartrate and its Formulation
Sandip D Firke, Nikhil A Patel, Ravindra R Patil
A simple, precise, accurate high performance thin layer chromatographic (HPTLC) method has been developed for estimation of cyamemazine tartrate from a bulk drug and combined dosage form. The separation of drugs was carried out on Merck HPTLC aluminium sheets of Silica gel 60 F254 TLC plates as stationary phase and the chromatogram was developed using Benzene: Methanol (4.2:0.8v/v) as the mobile phase. Cyamemazine tartrate showed Rf values 0.45, when scanned densitometrically at 260 nm using Camag TLC Scanner. The described method was linear over a concentration range of 200 ng/spot to 1200 ng/spot for cyamemazine tartrate. Results of analysis were validated according to International Conference on Harmonization ICH Q2B guidelines statistically, and by recovery studies. The limit of detection (LOD) and limit of quantification (LOQ) for cyamemazine tartrate was found to be 28.47 ng/spot 86.29 ng/spot respectively. The results of the study showed that the proposed HPTLC method is simple, rapid, precise and accurate, which is useful for the routine determination of cyamemazine tartrate bulk drug and in its pharmaceutical dosage form.

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