International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Simultaneous Estimation of Ambroxol Hydrochloride and Olopatadine in Formulated Tablet Dosage Form by UV Spectroscopic Method
Gaur A, Rathore P
A novel, simple, rapid, precise, accurate, cost effective and reproducible spectroscopic method has been developed for simultaneous estimation of ambroxol HCl and olopatadine in formulated combined tablet dosage form. The method employs measurement of absorbance at two wavelengths, 246.nm and 298nm, of ambroxol and olopatadine respectively. Beer´s law obeyed in the concentration range of 12-72µg/ml and 2-16µg/ml for ambroxol and olopatadine respectively. The proposed method is recommended for routine analysis since it is rapid, simple, accurate, and also sensitive and specific. Results of percentage recovery studies confirmed the accuracy of the proposed method. The present uv spectroscopic method was validated following the ICH guideline.

2. Method Development and its Validation for Simultaneous Estimation of Lornoxicam and Paracetamol as API and in Tablet Dosage form by UV Spectrophotometry using Hydrotropic Agents
Ajay Gaur, Yashwant, Randhir Singh
A simple, sensitive, economical UV Spectrophotometric method was developed for the simultaneous estimation of Lornoxicam and Paracetamol in bulk and tablet formulation by using Urea solution as Hydrotropic agent. The lmax for Lornoxicam and Paracetamol was found to be 384 nm and 244 nm respectively and both Lornoxicam and Paracetamol obey Beer-Lambert’s law in the concentration range of 2-10 µg/ml (r2=0.999) and 20-60 µg/ml.(r2=0.999) in 8M Urea (Hydrotropic agent) respectively. The developed method was validated according to ICH guidelines and value of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values.

3. RP-HPLC Method for Simultaneous Estimation of Metformin Hydrochloride, Pioglitazone Hydrochloride and Gliclazide as API and in Synthetic Mixture
Ajay Gaur, Yashwant
A new, simple, accurate, precise and selective reverse phase-high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Metformin hydrochloride, Pioglitazone hydrochloride and Gliclazide as API and in synthetic mixture is developed. The determination was carried out on a ODS, (250 X 4.6 mm, 5 μm) column using a mobile phase of buffer solution: acetonitrile (55:45 % v/v, pH 5.0). The flow rate was 1.0 ml/min with detection at 230 nm. The retention time for Metformin hydrochloride, Pioglitazone hydrochloride and Gliclazide were 2.11 min, 8.6 min and 10.49 min respectively. Metformin hydrochloride, Pioglitazone hydrochloride and Gliclazidel showed a linear response in the concentration range of 50-350 µg/ml, 1.5- 10.5 µg/ml and 6- 42 µg/ml respectively. The results of analysis have been validated statistically and by recovery studies. The mean recoveries found for Metformin hydrochloride was 99.05%, Pioglitazone hydrochloride was 99.91% and Gliclazide was 99.26%. Developed method was found to be simple, accurate, precise and selective for simultaneous estimation of Metformin hydrochloride, Pioglitazone hydrochloride and Gliclazide as API and in synthetic mixture.

4. Analytical Method Development and Validation of Formoterol Fumarate Dihydrate By Chromatographic and Spectrophotometric Techniques
Redasani V K, Bhavsar M S, Surana S J
Three simple, precise and economical methods have been developed and validated for estimation of Formoterol Fumarate Dihydrate in bulk and in pharmaceutical dosage form. Method A is simple UV spectrophotometric method for estimation of drug in phosphate buffer (pH 3) at 214 nm. Linearity was found in the conc. range of 2-12 µg/ml while the detection and quantitation limits were found to be 0.11 and 0.32 µg/ml respectively. Method B is the first- order derivative spectrometric technique performed at 229 nm, in which linearity was found in the conc. range of 2-12 µg/ml while the detection and quantitation limits were found to be 0.14 and 0.44 µg/ml respectively. Method C is RP-HPLC method in which separation was achieved by gradient elution using an Inertsil  (150 × 4.6 mm) column, a mobile phase consisting of sodium phosphate buffer (0.01M; pH 3.0): acetonitrile (70:30 v/v), a flow rate of 1.0 ml/min and UV detection at 214 nm. The linearity was obtained in the conc. range of 2-7 µg/ml while the detection and quantitation limits were found to be 0.04 and 0.14 µg/ml respectively. All the three methods were validated successfully across the guidelines in accordance with ICH. Thus, the proposed methods can be used for routine analysis of formoterol fumarate dihydrate as it does not showed any interference of excipients when estimated in pharmaceutical formulations.

5. Simultaneous Spectrophotometric Determination of Vitamin B6 by Coupling with p-Amino Phenol
Hind Hadi
A simple, rapid and sensitive spectrophotmetic method for trace determination of pyridoxine hydrochloride (PYR) in aqueous solution and in pharmaceutical preparations is described. The method is based on the oxidative coupling reaction of the intended compound with p-aminophenol (PAP) to form an intense purpule, water soluble dye that is stable and shows maximum absorption at 534 nm. A graph of absorbance versus concentration indicates that Beer’s law is obeyed over the concentration range of 50-1000 mg of PYR in a final volume of 25 mL (i.e. 2-40 ppm), with a molar absorbtivity 2.138×103, a sandell’s sensitivity of 0.0962 a relative standard deviation of 0.519-2.383 % depending on the concentration of PYR. The optimum conditions and stability of the colored product have been investigated and the method was applied successfully to the determination of PYR in dosage forms.

6. Development and Validation of UV-Spectrophotometric Method for Estimation of Cilostazol in Bulk and Pharmaceutical Dosage Form
Deokar Gitanjali S, Katoriya Veena S, Shinde Lavesh B, Raut Shaileshkumar, Chaure Sayali, Kshirsagar Sanjay
A simple efficient, precise and accurate spectroscopic method has been developed and validated for quantitative estimation of Cilostazol in bulk and pharmaceutical dosage form. Cilostazol is soluble in ethanol and phosphate buffer 6.8 pH respectively, so it was used as solvents. The resulting solution was then scanned in the UV range (800-400nm) in a 1 cm quartz cell in a double beam UV spectrophotometer. The λmax of Cilostazol was found to be 258 nm. The method obeys Beers law in the concentration range from 2-10 μg/ml. The correlation coefficient was found to be 0.999 (r2═ 0.999). The LOD and LOQ were found to be 1.7894and 5.4224μg/ ml respectively. The result of estimation of marketed formulation (Pletal) was found to be 99.1 %. The accuracy of the method was determined by recovery studies. The percentage recovery was found to be 100.44%. The method was validated statistically as per ICH guidelines. The method showed good reproducibility and recovery with % RSD less than 2. So, the proposed method was found to be simple, specific, precise, accuracy, linear, and rugged. Hence it can be applied for routine analysis of Cilostazol in bulk drug and the Pharmaceutical formulations.

7. A Mechanistic Approach of QbD for the Preparation and Evaluation of Immediate Release Tablet Containing Mycophenolate Mofetil and Prednisolone
Jasleen Kaur, Surajpal Verma, Narendra Kumar Pandey, Parth Sharma, Shruti Chopra, Shyam Baboo, Indu Bala
The aim of present study is to develop an optimized formulation as immediate release tablet containg Mycophenolate mofetil (250mg) and Prednisolone (5mg) using Quality by Design (QbD) concept. According to QbD, the Target product profile (TPP) was developed in which values of critical quality attribute of the product was predicated. Formulation variables and process variables were selected for initial risk assessment of the product, and for this purpose two design layouts were prepared using design expert software 8. The responses were the final evaluation parameters for the tablets, were disintegration time (Y1), dissolution times for MMF (Y2) and Prednisolone (Y3). To select the one good design layout predicted Vs actual results were compared by graphical analysis. Design layout 1 was selected for further data analysis to understand the effect of variables on CQA of product. Some statistical model (sequential mode of sum squares, model summary statics design, ANOVA) were applied on the data of both the design layouts and also draw the perturbation plot contours plot and 3D contours plot. The optimized batch containing Croscarmellose sodium (2.75% w/w), Polyvinylpyrrolidone K-30 (2.75% w/w), Aerosil (0.55 %w/w) and mixing time 45 minutes, as per design expert software, was finally validated.

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