SHRIKRISHNA BAOKAR

Worldwide the R & D divisions of Pharma industry are actively involved in the development of new therapeutic agents. These agents may be either new entities or partial structural modification of the existing one. The recent FDA statistics represent that the average number of drug filings are increasing every year in the thrust areas like anti-cancer agents, anti-diabetic, antibiotics, cardio-vascular drugs, respiratory drugs etc. Sodium glucose co-transporter-2(SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors and biguanides are effective oral anti-diabetic agents used in treatment of type 2 Diabetes Mellitus. Therefore, the necessity to explore and compare the existing analytical and bioanalytical assays used for determination of such drugs either single or in combination is crucial. Many methods were reported in the literature for the bio-analysis and analysis of four novel gliptins combinations, empagliflozin-linagliptin, empagliflozin-metformin HCl, linagliptin-metfo...

A RP-HPLC method was developed and validated for the simultaneous estimation of Vildagliptin (VIDA) and Metformin Hydrochloride (MET) in bulk and pharmaceutical dosage form. Chromatography was carried on Warers HPLC, Lichrocart C18 column (250 x 4.60 x 5μm) with mobile phase comprising of 0.05 M KH2PO4: Acetonitrile (70:30 v/v pH 3.5 with Ortho Phosphoric Acid). The flow rate was adjusted to 1.0 ml/min with UV detection at 215 nm. The retention times of VIDA and MET were found to be 6.64 and 5.18 minutes respectively. The different analytical parameters such as accuracy, linearity, precision, robustness, ruggedness were determined according to the ICH Q2B guidelines. The detector response was linear in the range of 5–25 μg/ml, 10–50 μg/ml for VIDA and MET respectively. In the linearity study, the regression equation and correlation of coefficient for VIDA and MET were found to be (y = 1014x + 54.43, R2 = 0.999) and (y = 307.8x + 146.0, R2 = 0.999) respectively. The proposed method i...

A Simple, sensitive, specific, spectrophotometric method has been developed for the detection of Lumefantrine in pure and Pharmaceutical formulations. The optimum condition for the analysis of the drug was established. Lumefantrine shows maximum absorption at 228 nm and obeyed beers law in the concentration range 10 to 50 μg/ml. The correlation coefficient was found to be 0.999 and slope of line was found to be 0.0635. The percent S.D. for intra assay precision of the method was found to be 1.85% whereas Inter assay precision was found to be 0.44%. The sample solution was stable up to 24 hours. The assay results were found to be in good agreement with label claim. The proposed method was simple sensitive, precise, quick and useful for routine quality control.

ABSTRACT Objective To evaluate the antidepressant activity of methanolic extract of rhizomes of Acorus calamus (A. calamus).Methods Tail suspension test (TST) and forced swimming test (FST) in mice were used to evaluate the antidepressant activity of methanolic extract of rhizomes of A. calamus. Methanolic extracts (50 and 100 mg/kg i.p.) were administered daily for 7 days. Imipramine 5 mg/kg was used as standard antidepressant agent throughout the study.ResultsTest extracts of A. calamus decreased immobility periods significantly in a dose dependent manner in both TST and FST. The observed results were also comparable with known standard drug i.e. imipramine. The flavonoid apigenin, which selectively binds with high affinity to the central benzodiazepines receptor, possesses important anxiolytic and antidepressant activities. The review of literature reveals that the A. calamus contains saponin, glycosides, tannin and flavonoid.Conclusions Methanolic extract of A. calamus rhizomes shows antidepressant activity probably through interaction with adrenergic, dopaminergic serotonergic and γ-aminobutyric acid (GABA) nergic system. Both the models have been proved to be equally valuable for demonstration of substances with a potential antidepressant activity.

In this study, UV spectrophotometric method at 276nm was developed for the determination of Venlafaxine in commercial dosage forms. Optical Density (OD) measurement was used in calculating the concentration of the drug samples drawn from dissolution test (temp 37 ± 0.5˚C) at ...

This study Study was aimed at develop and validate RP- HPLC method for the assay of sildenafil citrate in tablets’ formulation A chromatographic system comprising Partisil 10 ODS C18 (250 x 4.6 mm, 5μm) column, a mobile phase of Buffer solution (pH2.0): acetonitrile, a flow rate of 1.5 ml/min and a UV detector set at 228 nm has shown good chromatographic separation for sildenfil. The degree of linearity of the calibration curves, the percent recoveries of sildenafil and related substances, the limit of detection (LOD), and limit of quantitation (LOQ) for the HPLC method have been determined. The HPLC method under study was found to be specific, precise, accurate, reproducible indicating stability and robust

A Simple, sensitive, specific, spectrophotometric method has been developed for the detection of Sildenafil citrate in pure form and Pharmaceutical formulations. The optimum condition for the analysis of the drug was established. Sildenafil citrate exhibiting absorption at 228nm and obeyed beers law in the concentration range 10 to 50µg/ml. The correlation coefficient was found to be 0.9998 and slope of line was found to be 0.07877. The percent S.D. for intra assay precision of the method was found to be 1.9976% whereas Inter assay precision was found to be 0.8332%. The sample solution was stable up to 24 hours. The assay results were found to be in good agreement with label claim. The degradation study was checked at different conditions like with acid, alkali, dry heat, oxidative and photolytic. All the results found in degradation study were satisfactory. So this proposed method was simple sensitive, precise, quick and useful for routine quality control.

A rapid dissolution method was developed for the evaluation of Acyclovir tablets and the determination of Acyclovir content was done by UVspectrophotometer. The proposed method comprises the measurement absorbance of standard concentrations of Acyclovir in the pH 7.4 phosphate buffer solution against wavelength maximum [λmax] of 251 nm. Beer's Law limits were obeyed in the concentration range of 1μg/ml – 10 μg/ml against absorbance. The linear regression coefficient was estimated to be 0.999 and the linear regression equation obtained was y=0.0954x-0.0014. The solutions were stable for more than 12 hours. The method has been extended for the determination of Acyclovir content in tablets after the dissolution for 45 minutes at 50rpm using USP Apparatus II [Paddle apparatus] under experimental conditions. The unknown concentration of Acyclovir in the solution was estimated from the standard curve and it was found to be within the range of the labeled claim. The RSD of six replicat...

The medicinal herb Dioscorea floribunda (Linn.) is very significant. Varahikanda's medicinal properties are quite important. It is used to treat various diseases in Ayurvedic literature. Here is a summary of studies on the antiquity and ayurvedic qualities of varahikanda, i.e. Dioscorea floribunda. Varahikanda has a variety of pharmacological characteristics, according to the research. Jeevaneeya, Rasayana, Balya, Krumighna, Pramehaghna, Kushtaghna, Vrushya, Nadivrun, Visarpa, Udarshool, Raktapitta are all Ayurvedic terms. It has antimicrobial action, wound healing activity, antihyperglycemic activity, dyslipidemic activity, anticancer activity, immunomodulatory activity, antioxidant activity, antiinflammatory and analgesic activity, antihelmintic activity, and aphrodisiac activity, according to contemporary research.

Prazosin Hydrochloride (PRZ) is an antihypertensive agent which is one of the leading marketed drugs in the world. A rapid, specific and economic UV spectrophotometrically method has been developed using methanol as a solvent to determine the PRZ content in bulk and pharmaceutical dosage formulations. At a pre-determined Λmax of 2 nm, it was proved linear in the range of 1 -5 μg/mL, and exhibited good correlation coefficient (R2=0.999) and excellent mean recovery. This method was successfully applied to the determination of PRZ content in one marketed brand from India and the results were in good agreement with the label claim. The method was validated statistically and by recovery studies for linearity, precision, accuracy, ruggedness, robustness, LOD and LOQ. The obtained results proved that this method can be employed for the routine analysis of PRZ in bulks as well as in the commercial formulations.

... 14. Deshpande PB, Shridharan G, Anandi Libi, Jadhav D, Damle MC, Gandhi SV; Validated Method Development for Estimation of Atorvastatin ... Mishra P, Gupta A, Shah K; simultaneous estimation of atorvastatin calcium and amlodipine besylate from tablets, Indian journal of ...

... 14. Deshpande PB, Shridharan G, Anandi Libi, Jadhav D, Damle MC, Gandhi SV; Validated Method Development for Estimation of Atorvastatin ... Mishra P, Gupta A, Shah K; simultaneous estimation of atorvastatin calcium and amlodipine besylate from tablets, Indian journal of ...

Loperamide is an opioid receptor agonist and acts on the mu opioid receptors in the myenteric plexus large intestines; it works specifically by decreasing the activity of the myenteric plexus which decreases the motility of the circular and longitudinal smooth muscles of the intestinal wall. Loperamide is a synthetic anti-diarrheal indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Loperamide HCl, fast dissolving tablets have been prepared by direct compression method by using kneading mixture of Loperamide HCl and Crospovidone, after incorporating superdisintegrants such as Ac-di sol, Sodium starch glycolate, in different concentrations. All the formulation were evaluated for the influence of disintegrants and their concentrations on the characteristics of fast dissolving tablets mainly in terms of disintegration time and dissolution rate. Tablets containing Ac-di-sol at high concentrati...

A Simple, sensitive, specific, spectrophotometric method has been developed for detection of Metformine Hydrochloride in pure and pharmaceutical formulations. The optimum condition for the analysis of the drug was established. Metformine exhibits absorption at 228 nm and obeyed beers law in the concentration range 02 to 10 ppm. The correlation coefficient was found 0.9988 and slope of line 0.1148. The %R.S.D. for intra assay precision of the method was found 1.08 whereas Inter assay precision was found to be 0.4433 (Average). The sample solution was stable up to 24 hours. The assay results were found to be in good agreement with label claim. The degradation study was checked at different conditions like with acid, alkali, dry heat, oxidative and photolytic degradation. All the results found in degradation study were satisfactory. So this proposed method was simple sensitive, precise, quick and useful for routine quality control.

A simple, precise and accurate difference spectroscopic method has been developed for the estimation o f Acyclovir in bulk and in pharmaceutical dosage form. The proposed method is based on the principle that Acyclovir can exhibit two different chemical forms in basic and acidic medium that differ in the absorption spectra in basic and acidic medium. Since the drug was freely soluble in distilled water, a stock solution (1 mg/mL) was prepared with distilled water. Further dilution was made by using 0.1 M sodium hydroxide and 0.1 M hydrochloric acid separately. The maxima and minima in the difference spectra of Acyclovir were at 256 nm. Difference in absorbance between these maxima and minima was calculated to find out the amplitude. This amplitude was plotted against concentration. Beer’s law is valid in the concentration range of 1-5μg/mL. As per ICH guidelines results of analysis were validated statistically and all the results we re found satisfactory.

A rapid dissolution method was developed for the evaluation of Roxithromycin tablets and the determination of Roxithromycin content was done by UV-spectrophotometer. The proposed method comprises the measurement absorbance of standard concentrations of Roxithromycin in the pH 6.0 phosphate buffer solution against wavelength maximum [λmax] of 205 nm. Beer's Law limits were obeyed in the concentration range of 1µg/ml – 10µg/ml. The linear regression coefficient was estimated to be 0.999 and the linear regression equation obtained was y=0.0954x-0.0014. The solutions were stable for more than 12 hours. The method has been extended for the determination of Roxithromycin content in tablets after the dissolution for 60 minutes at 50 rpm using USP Apparatus II [Paddle apparatus] under experimental conditions. The unknown concentration of Roxithromycin in the solution was estimated from the standard curve and it was found to be within the range of the labeled claim. The relative standard...

A simple, precise, accurate, cost effective and reproducible spectrophotometric method has been developed for simultaneous estimation of Vildagliptin (VIDA) and Metformin (MET) in combined tablet dosage form. The method employs measurement of absorbance at the wavelength of maximum absorptions of VIDA and MET using 0.1 N NaOH as a solvent. The calibration curve was linear in concentration range of 30-70 μg/ml for VIDA with correlation coefficient of 0.999 and 5-25 μg/ml for MET with correlation coefficient of 0.999. Accuracy of proposed method was confirmed by performing accuracy studies which showed the accepted results. Precision of proposed method was confirmed by performing intraday and inter day precision. All the results were well within acceptance criteria which indicates the method has excellent scope for simultaneous estimation of VIDA and MET in combined dosage form.

ABSTRACT:
A RP-HPLC method was developed and validated for simultaneous estimation of montelukast and ebastine in bulk as
well as in tablet formulation according to ICH guidelines. The chromatographic separations of drugs were achieved on
Younglin (S.K) isocratic system with Lichrocart C18 column (4.6 mm×250 mm, 5μm). The mobile phase consisted by
methanol and water (80: 20) at pH 3 adjusted by ortho phosphoric acid. The flow rate was adjusted to 1 ml/min and
UV detection was carried out at 268 nm. The retention time for montelukast and ebastine were found to be 6.56 and
2.95 min respectively. The detector was showed linear responses over the concentration range 5 – 25 μg/mL for both
drugs by showing a good correlation coefficient of 0.999. This proposed method is highly sensitive, precise and
accurate which reduces cost of analysis; hence recommended for routine quality analysis in laboratories.

ABSTRACT
A Simple, sensitive, specific, spectrophotometric method has been developed for the detection of
Lumefantrine in pure and Pharmaceutical formulations. The optimum condition for the analysis of the
drug was established. Lumefantrine shows maximum absorption at 228 nm and obeyed beers law in the
concentration range 10 to 50 μg/ml.
The correlation coefficient was found to be 0.999 and slope of line was found to be 0.0635. The percent
S.D. for intra assay precision of the method was found to be 1.85% whereas Inter assay precision was
found to be 0.44%. The sample solution was stable up to 24 hours. The assay results were found to be in
good agreement with label claim.
The proposed method was simple sensitive, precise, quick and useful for routine quality control.

ABSTRACT
Objective: The aim of present work was to develop a RP-HPLC method for simultaneous analysis of
Dicyclomine (DCL) and Mefanamic acid (MFA) in a tablet dosage form. Method: Waters Chromatographic
system was optimized using a Lichrocart C18 column (250 x 4.60 x 5ìm) with mobile phase comprising of
50 mM KH2P04: Acetonitrile in the ratio of 75:25. The flow rate was adjusted to 1.0 ml/min with UV detection
at 256 nm. Result: DCL and MFA were eluted with retention times of 7.213± 0.3 min and 11.102± 0.3 min
respectively. Beer’s Lambert’s Law was obeyed over the concentration ranges of 5-25 ìg/ml, 50-250 ìg/ml
for DCL and MFA respectively. Conclusion: The high recovery and low coefficients of variation confirm
the suitability of the method for simultaneous analysis of both drugs in a tablet dosage form. Statistical
analysis proves that the method is sensitive and significant for the analysis of DCL and MFA in pure and in
pharmaceutical dosage form without any interference from the excipients. The method was validated in
accordance with ICH guidelines.