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89 International Journal of Analytical and Bioanalytical Chemistry 2011; 1 (3): 89-101

ISSN-2231-5012

Original Article

FORMULATION OF DOSAGE FORM OF ROSUVASTATIN CALCIUM AND

DEVELOPMENT OF VALIDATED RP-HPLC METHOD FOR ITS ESTIMATION

Anup Kumar Chakrabortya*, Sudha Ranjan Mishra

b, Himanshu bhusan Sahoo

b

Department of Pharmaceutical Chemistry, People's Institute of Pharmacy and Research Centre,

People’s University, Bhanpur, Bhopal, MP, India bDeparment of Pharmacology, Vedica college of Pharmacy, Bhopal, MP, India.

E-mail: [email protected]

Received 27 November 2011; accepted 09 December 2011 Abstract

A new, simple, precise, rapid, and accurate reverse phase liquid chromatographic method for formulation containing

Rosuvastatin Calcium as active pharmaceutical ingredients has been explained in this paper. A Phenomenex-C18 (250 x

4.6mm) with a particle size of 10 column was used with a mobile phase containing a mixture of Buffer: Acetonitrile in the ratio 55:45. The flow rate was 1.0ml/min and effluents were monitored at 244nm and eluted at 6±0.5 min. The assay was

validated for the parameters like accuracy, precision, robustness and system suitability parameters. The proposed method can

be useful in the routine analysis for the determination, development and to validate a new High Performance Liquid Chromatographic method (HPLC) for such an analysis.

© 2011 Universal Research Publications. All rights reserved

Keywords: Rosuvastatin Calcium, RP-HPLC, validation, formulation.

1.1 INTRODUCTION

Method validation is the process used to confirm

that the analytical procedure employed for a specific test is

suitable for its intended use. Results from method validation

can be used to judge the quality, reliability and consistency of

analytical results; it is an integral part of any good analytical

practice. So the present work is to develop and validate a new High Performance Liquid Chromatographic method (HPLC)

for such an analysis. [1.2] Chromatographic methods are

commonly used for the quantitative and qualitative analysis

of raw materials, drug substances, drug products and

compounds in biological fluids. The components monitored

include chiral or achiral drug, process impurities, residual

solvents, excipients such as preservatives, degradation

products, extractable and leachables from container and

closure or manufacturing process, pesticide in drug product

from plant origin, and metabolites. [3]Methods should be

reproducible when used by other analysts, on other equivalent

equipment, on other days or locations, and throughout the life

of the drug product [4, 5]

Rosuvastatin calcium is a potent inhibitor of

3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA)

reductase, which is used for the treatment of hyperchole-

sterolemia. HMG-CoA reductase is the rate-limiting enzyme

in de novo cholesterol synthesis. HMG-CoA reductase inhibitors reduce the production of mevalonic acid from

HMG-CoA, resulting in a reduction in hepatic cholesterol

synthesis. This in turn results in a compensatory increase in

the expression of high affinity low-density lipoprotein (LDL)

receptors on hepatocyte membranes and stimulation of LDL

catabolism. It is in this manner that produces the lowering of

plasma total and LDL cholesterol levels observed in patients

with hypercholesterolemia. Reductions in the hepatic pool of

cholesterol have also been associated with a decrease in the

rate of production of very-low-density lipoprotein (VLDL)

and/or LDL by the liver. The high potency of relative to other

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International Journal of Analytical and Bioanalytical Chemistry

Universal Research Publications. All rights reserved

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Figure No. 1: Chemical structure of Rosuvastatin Calcium

IUPAC Name- bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-

[methyl(methyl sulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-

dihydroxyhept-6-enoic acid] calcium

statins probably relates to’s low lipophilicity and high

hepatocyte selectivity due to its large polar side chain. [6, 7]

Rosuvastatin calcium is a reversible competitive

inhibitor of HMG-CoA reductase, which is the most

important rate-limiting enzyme that converts 3-hydroxy-3-

methylglutaryl coenzyme A to mevalonate, a precursor for

cholesterol [8, 9]. It is more potent than other statins such as

atorvastatin, simvastatin and is 8-fold more potent than the

hydrophilic comparator, pravastatin [9, 10, 11]. Literature survey

reveals that an HPLC method was developed for quantitative

determination of rosuvastain in the presence of its

degradation products in raw material (Hasumati A. Raj et.al.),

HPLC method for the estimation of rosuvastatin (RST) in rat plasma (Thammera ranjith kumar et.al), liquid

chromatography/tandem mass spectrometry method for the

quantification of rosuvastatin in human plasma (Ke Lan

et.al), microbore high-performance liquid chromatography

(HPLC) in combination with tandem mass spectrometry

(MS/MS) for the sensitive detection of rosuvastatin

(Crestor™) in human plasma (Kathalijne A. Oudhoff et.al.)

and an HPLC method for the simultaneous quantitation of

five 3-hydroxy-3-methyglutaryl coenzyme A (HMG-CoA)

reductase inhibitors, viz. atorvastatin, lovastatin, pravastatin,

rosuvastatin and simvastatin, in pharmaceutical formulations

and extended the application to in vitro metabolism studies of these statins (Pasha, Md Khalid et.al). This paper describes a

simple, sensitive, validated and economic method for the

determination of Rosuvastatin Calcium in bulk and

pharmaceutical dosage forms.

1.2 EXPERIMENTAL

1.2.1 Materials

Ammonium Acetate (AR Grade), Glacial acetic acid (AR

Grade), Triethylamine (AR Grade), Acetonitrile (HPLC

Grade), Rosuvastatin calcium (IP), Lactose DCL-15 (BP), Tri

basic calcium phosphate(BP), Microcrystalline Cellulose

(Sancel PH -102, BP), Cross Povidone (BP), Magnesium

stearate (BP).

1.2.2 Instrumentation

The HPLC system consisted of a HPLC-2010CHT-Shimadzu (lass-VP& LC Solution Software) connected with UV VIS

Detector Winchrome EX. Analysis was carried out at 255nm

using a Phenomenex-C18 (250X4.6mm, 10µ) and Inertsil-

C18 (250X4.6mm,10µ) at ambient temperature. Other

instruments used were Sonicater-Cole Parmer, PH Meter-

Model-744 Methom. For dissolution profile USP-II (Paddle)

is used.

1.2.3 Formulation development by dry mixing process

Accurately weigh and pass Rosuvastatin calcium Calcium

through 60#u.Pass Tribasic calcium phosphate,

microcrystalline cellulose(Sancel pH102), Lactose.DCL-15

through 30# mix with the above mixture. Pass crosspovidone & Mg. Stearate through 40# and add crosspovidone with step

2 for 20 min. Lubricate with mg.stearate for 5 min and then

for tooling use 7 mm punch (Table No. 1).

1.2.4 Formulation development for Film Coating

Suspend HPMC-6CP & talcum in 2500ml isopropyl alcohol

by using a mechanical stirrer. Add methylene chloride 4500

ml in above mixture and continue stirring till clear mucilage

is formed. Then add titanium dioxide in 500 ml of isopropyl

alcohol with continuous stirring will dispersed uniformly.

Then pass the mixture through double muslin clothes 200#.

Add step 3 to step 2 with constant stirring for complete distribution. Add Propylene Glycol in step 4 with continuous

stirring. Pass the final solution to muslin cloth. (Table No. 2)

1.2.5 Dissolution procedure for the formulated tablets

1.2.5.1 Preparation of standard solution:

Accurately weigh 50 mg of Rosuvastatin WS equivalent

to 52.085 mg Rosuvastatin calcium & transfer to a 100 ml

volumetric flask. Add 20 ml of methanol & sonicate for 5.0

minutes, make up the volume with methanol. From the above

solution take 1.0 ml & transfer to a 25 ml volumetric flask,

make up the volume with dissolution media (Concentration

20.0 mcg / ml).

1.2.5.2 Preparation of dissolution sample

The preparation of dissolution sample is tabulated in Table

No. 3, 4 and 5.

1.2.6 Preparation of standard and stock solution

A-Buffer preparation

Prepare 0.02 molar ammonium acetate buffer .add 2ml of

triethyl amine & adjust the PH to5.0 with Glacial acetic acid.


R2 = 0.998

800000

900000

1000000

1100000

1200000

1300000

1400000

1500000

1600000

70% 80% 90% 100% 110% 120% 130%

Concentration

AR

EA

Figure No. 2: Graphical representation of linearity data.

Figure No. 3: Graphical representation of dissolution profile of Rosuvastatin calcium (10 mg) tablets

B-Mobile phase preparation:-Prepare a filtered & degassed

mixture of buffer& acetonitrile in the ratio of 55:45.

C-Standard preparation:-Weigh accurately 26mg of

Rosuvastatin calcium working standard equivalent to 25 mg

of into Rosuvastatin 50 ml of volumetric flask and to it add 30

ml of mobile phase and sonicate for 10 minutes. Cool to room

temperature and then make up the volume up to the mark with

mobile phase. Dilute 1.0 ml of this solution to 25 ml with mobile phase to get a solution of 20 mcg/ml.

D-Sample preparation: - weigh and crush 20 tablets and take

mixed crushed powder equivalent to 1 mg of Rosuvastatin

into 50 ml volumetric flask and to it add 30 ml of mobile

phase and sonicate for 15 minutes. Cool to room temperature

and then make up the volume up to the mark with mobile

phase. Filter the solution to 0.45µ filter paper to get a solution

of 20 mcg /ml.

Procedure–Separately injects 20µl of the standard

preparation and assay preparation into the chromatogram,

record the chromatograms and measure the responses for the

major peaks.

1.3 RESULTS AND DISCUSSION

1.3.1 Formulation of the tablets

The composition of the product and method for manufacturing

is satisfactory and reproducible and is decided to continue

with the same formulation & method to ensure reproducibility

and quality.

1.3.2 Specificity

Placebo solutions, mobile phase as blank, placebo

spike with standard solution were analyzed as per the method

to examine the interference of placebo & mobile phase

solution with Rosuvastatin peaks. Peak purity analysis for

Rosuvastatin peaks indicates that the peak is homogeneous &

there is no interference peaks, thus proving specificity of the

method. Peak purity plot of the analyte peaks &

representative chromatograms of placebo, mobile phase


blank, placebo spike with standard. The area of bank,

placebo, standard & test are given in below table no. 6.

1.3.3 Linearity and range

A series of solutions are prepared using Rosuvastatin

Calcium working standard at concentration levels from 70 %

to 130 %. (Table no. 7, Figure no. 1). Range of analytical method can be obtained from the linearity, precision and

accuracy data. The range should be reported in % with respect

to test concentration. It can be conclude from the linearity,

precision and accuracy experiments, the range of analytical

method for the assay Rosuvastatin calcium was 80% to 120%

of test concentration.

1.3.4 Precision

1.3.4.1 System precision

Six replicate injections of standard solution at the

concentration of 20 mcg /ml were injected into HPLC system.

The area response of individual analyte along with % RSD

tabulated in Table no. 8. The % RSD observed on the replicate indicates the precision of the system

1.3.4.2 Method Precision

Six replicate samples from homogeneous powdered blend of

Rosuvastatin calcium tablets were analysed as per the

method. (The percentage of label claim calculated) the results

are tabulated in table no. 9, 10 and 11.The percentage of

Rosuvastatin calcium in the portion of tablet is calculated by;

Where,

Mol wt of Rosuvastatin Calcium=1001.14

Mol wt of Rosuvastatin =961.06

LC = Label claim. From the above six assay results of

rosuvastatin calcium we concluded that the% RSD is 1.06

which indicates that the method precision is within the

acceptance criteria & method is validated for method

precision.

1.3.4.3 Intermediate Precision

The intermediate precision of the method was

determined by six replicate samples from homogeneous

powder blend of rosuvastatin calcium by two different analyst

using two different instruments different columns on different

days. The statistics data were given in table no.12, 13 and 14.

The average assay and the relative standard deviation (%RSD) were calculated

Where, Mol wt of Rosuvastatin Calcium=1001.14

Mol wt of Rosuvastatin =961.06

LC = Label claim

From the above six assay results of rosuvastatin calcium we

concluded that the% RSD is 0.30 which indicates that the

intermediate precision is within the acceptance criteria &

method is validated for intermediate precision.

1.3.5 Accuracy (Recovery)

A known amount of placebo eq. to 1mg of Rosuvastatin was

taken in flasks and spiked with known amount of

Rosuvastatin at three different levels like 80%, 100% 120% in

triplicate. A sample was analyzed as per the proposed method

and results are tabulated in table no. 15 and 16. The overall %

of recovery for Rosuvastatin in Rosuvastatin table is

between100-101%. Therefore, the accuracy of the method is

considered to be acceptable as it is within the limit of 98 to

102 %.

1.3.6 Ruggedness

Six preparation individually were prepared using single batch of Rosuvastatin Calcium and injected each solutions in

duplicate using different column, system, analyst on different

days were used and the results are tabulated in table no. 17.

Test results are showing that the Test Method was Precise.

1.3.7 Robustness

The robustness of the method was determined by performing

system suitability analysis of standard under variable

conditions. The acceptance Criteria i.e. overall RSD should be

not more than 2.0 %. (Table no. 18-28)

The test method was validated for Specificity,

linearity, precision; Accuracy, Range, Ruggedness and Robustness are found to be meeting the predetermined

acceptance criteria. The validated method was found to be

Specific, Linear, Precise, Accurate, and Robust for the assay

of tablets

1.3.8 Method development

Mobile phase: Buffer (6.4): Acn (80:20V/V), Diluent Buffer

(6.4): Acn (55:45V/V) flow rate 1.0ml/minute, runtime

20mins, injection volume 20µl, column temp 25ºC

Wavelenth240nm

1.4 CONCLUSION

The test method was validated for Specificity, linearity, precision; Accuracy, Range, Ruggedness and Robustness are

found to be meeting the predetermined acceptance criteria.

The validated method was found to be specific, linear, precise,

accurate and robust for the assay of tablets. The

chromatographic method for the determination of test

procedures of Assay for Rosuvastatin calcium in bulk drug,

raw materials and tablets were simple, reliable, sensitive and


BLANK

PLACEBO


Table:-1 Formulation development by dry mixing process

Table:-2 Film Coating of tablets.

Sr.

no.

Ingredient

Spec. Qty./ tab.

(Mg)

Qty for 50000 tablets

(gm)

1 HPMC-6CP BP 3.5 175.0

2 Titanium dioxide USP 0.36 18.0

3 Talcum BP 0.3 15.0

4 Methylene chloride BP 0.09 ml 4500ml

5 Isopropyl alcohol BP 0.06ml 3000ml

6 Propylene Glycol BP 0.3 15.0

Dissolution Profile:

Table: 3 Dissolution Data of Rosuvastatin calcium after 10 minutes:

Sample No. % of Drug Release Mean % of Relative Standard Deviation (RSD)

Sample 1 67.31

70.28

5.61 Sample 2 66.56

Sample 3 69.57

Sample 4 68.07

Sample 5 73.84

Sample 6 76.36



Sample 1 86.12

81.46

5.60 Sample 2 76.05

Sample 3 84.61

Sample 4 77.56

Sample 5 78.57

Sample 6 85.87



Sample 1 102.54

99.20

2.33 Sample 2 96.70

Sample 3 101.53

Sample 4 97.97

Sample 5 98.74

Sample 6 97.72

Sr

No.

Ingredient

Spec. Label

Claim

Qt/ tab

(Mg)

1 Rosuvastatin calcium Calcium eq. to

Rosuvastatin calcium

IH 10.0 10.42

2 Lactose DCL-15 BP 63.0

3 Tribasic Calcium Phosphate BP 29.5

4 Crosspovidone BP 8.08

5 Microcrystalline Cellulose (Sancel-pH-102) BP 114.0

6 Magnesium Stearate BP 5.0

Total 230


Table no.6: Data for Specificity

Table no.7: Data for linearity

Concentration Injection-1 R2 VALUE

70 % 858563

0.99803

80 % 957466

90 % 1058659

100 % 1188888

110 % 1309987

120 % 1420860

130 % 1512028

Table no. 8: Data for system precision

Standard 20 mcg/ ml

Sample No. Std Reading Mean Standard

Deviation %RSD

Injection-1 1191015

1192639

1373.24035

0.12

Injection-2 1191177

Injection-3 1194409

Injection-4 1193818

Injection-5 1192955

Injection-6 1192462

Acceptance Criteria: NMT 2.0 % (% of Relative Standard Deviation)

Test Data Collection of Rosuvastatin calcium

Table:-9 Standard Precision

Table: 10 Sample Precision

Name Area Average Retention time

Blank Nill

Nill

Placebo Nill Nill

Standard-1 1202586

1201621

6.492

Standard-2 1200655 6.475

Standard + Placebo 1215287 6.508

Concentration (ppm) Method

precision(Mp)

Sample

Injection Average

Standard

deviation %RSD

20 MP-1 1193735

1193642

564.37860

0.05

20 MP-2 1193461

20 MP-3 1193555

20 MP-4 1194796

20 MP-5 1193479

20 MP-6 1192826

Concentration

(ppm)

Method

precision(Mp)

Sample Injections Mean

Inj-1 Inj-2 Average

20 Mp-1 1204092 1217059 1210575.5 1203530

20 Mp-2 1204759 1202040 1203400

20 Mp-3 1206829 1202333 1204581

20 Mp-4 1202310 1201119 1201714.5

20 Mp-5 1200369 1200755 1200562

20 Mp-6 1200407 1200280 1200344


Table No. 11: Assay for Six Replicates of Rosuvastatin


Test Data Collection of Rosuvastatin calcium (Intermediate precision)

Table no. 12: Standard Precision

Table No. 13: Sample Precision

Table No. 14: Assay for Six Replicates of Rosuvastatin

Sample No. Estimated Amount

(in percentage)

Mean

(In percentage) Standard deviation %RSD

Sample 1 99.12

99.70

0.30

0.30

Sample 2 99.69

Sample 3 99.81

Sample 4 99.90

Sample 5 99.82

Sample 6 99.89


Sample No. Estimated Amount (in percentage) Mean (In percentage) Standard

deviation

%RSD

Sample 1 99.72

98.43

1.04

1.06

Sample 2 99.13

Sample 3 96.65

Sample 4 98.56

Sample 5 98.05

Sample 6 98.45

Concentration

(ppm)

Method

precision(Mp)

Sample Injection Average Standard

deviation

%RSD

20 MP-1 993338

998434

2584.28401

0.26

20 MP-2 999337

20 MP-3 998421

20 MP-4 999515

20 MP-5 1000522

20 MP-6 999473

Concentration

(ppm)

Method

Precision

(Mp)

Sample Injections Mean

Standard

deviation %RSD

Inj-1 Inj-2 Average

20 Mp-1 1020451 1026346 1023399

1030165 4952.29 0.481

20 Mp-2 1021570 1028207 1024889

20 Mp-3 1030839 1038986 1034913

20 Mp-4 1028099 1034817 1031458

20 Mp-5 1034785 1035231 1035008

20 Mp-6 1026288 1036358 1031323


Table No. 15: Data for accuracy (recovery)

Concentration

(ppm)

Method

precision(Mp)

Standard

Injection

Average Standard

deviation

%RSD

20 MP-1 1193607

1196267

1682.938

0.141

20 MP-2 1195025

20 MP-3 1196648

20 MP-4 1196546

20 MP-5 1197698

20 MP-6 1198076

Table No.16: Data for accuracy (recovery)

Recovery

Level

Resultant

Solution

(ppm)

Standard

Injections

Percentage

Recovery

Mean %

Recovery

Standard

deviation

%RSD

80% (A) 80 960286 1.0082

100.91

2562.17

0.267

80% (B) 80 959200 1.0071

80% (C) 80 964080 1.0122

100% (A) 100 1197786 1.009

100.81

1282.36

0.107

100% (B) 100 1196954 1.0083

100% (C) 100 1195269 1.0069

120% (A) 120 1434777 1.0059

100.6

380.045

0.026

120% (B) 120 1435350 1.0063

120% (C) 120 1434631 1.0058

Acceptance Criteria: Recovery should be within 98.0% to 102.0%

Table No. 17: Data for ruggedness

S.No. Concentration (ppm) Method precision (Mp) Inj 1 Inj2 Average

1

20

Mp-1 1194832 1192835 1193834

2 Mp-2 1197942 1198043 1197973

3 Mp-3 1189851 1187591 1188721

4 Mp-4 1198765 1199123 1198944

5 Mp-5 1180988 1180786 1180887

6 Mp-6 1189851 1180920 1185386

Mean 1195958

Standard

deviaation 7193.528

%RSD 0.604


Table No. 18: Change in wavelength: +5nm (249nm)

Table No. 19: Change in wavelength: -5nm(239nm)

Name Concentration (PPM) Area Relative retention time

S-1 20 1178176 6.358

S-2 20 1171983 6.333

S-3 20 1172565 6.317

S-4 20 1180086 6.342

S-5 20 1174024 6.308

S-6 20 1173328 6.308

Average 1175027 6.328

Std, Dev. 3308.46405

%RSD 0.28

Table no.20: Change in Column temperature: +50C(30

0C)


S-1 20 1200320 6.225

S-2 20 1200660 6.225

S-3 20 1201136 6.225

S-4 20 1202214 6.225

S-5 20 1202247 6.225

S-6 20 1202799 6.225

Average 1201563 6.225

Std, Dev. 996.20674

%RSD 0.08

Table no. 21: Change in Column temperature:-5 0

C(200

C)


S-1 20 1202928 6.40

S-2 20 1204190 6.4

S-3 20 1204321 6.4

S-4 20 1203477 6.392

S-5 20 1202510 6.383

S-6 20 1201581 6.383

Average 1203168 6.393

Std, Dev. 1046.75755

%RSD 0.09

Name Concentration (ppm) Area Relative retention time

S-1 20 1091347 6.258

S-2 20 1091398 6.275

S-3 20 1099005 6.350

S-4 20 1101788 6.400

S-5 20 1101494 6.483

S-6 20 1101321 6.483

Average 1097726 6.375

Std, Dev. 5019.8158

%RSD 0.46


Table no. 22: Change in Mobile phase +2%ACN


S-1 20 1187647 6.275

S-2 20 1189667 6.258

S-3 20 1188135 6.267

S-4 20 1185256 6.267

S-5 20 1183810 6.275

S-6 20 1182546 6.275

Average 1186177 6.270

Std, Dev. 2749.90381

%RSD 0.23

Table no. 23: Change in Mobile phase -2%ACN


S-1 20 1215663 6.275

S-2 20 1193644 6.258

S-3 20 1193708 6.258

S-4 20 1194190 6.258

S-5 20 1194503 6.258

S-6 20 1194332 6.258

Average 1197673 6.261

Std, Dev. 8819.71241

%RSD 0.74

Table no. 24: Change in Mobile phasePH

:+0.2(PH

5.2)


S-1 20 1181415 6.283

S-2 20 1182646 6.292

S-3 20 1179958 6.292

S-4 20 1179945 6.291

S-5 20 1178748 6.293

S-6 20 1177742 6.286

Average 1180076 6.289

Std, Dev. 1768.61784

%RSD 0.15

Table no. 25: Change in Mobile phase PH

0.2(PH

4.8)


S-1 20 1174190 6.300

S-2 20 1176242 6.300

S-3 20 1174754 6.308

S-4 20 1174987 6.300

S-5 20 1172949 6.300

S-6 20 1171062 6.292

Average 1174031 6.300

Std, Dev. 1807.54814

%RSD 0.15


Table no. 26: Change in Flow rate +10%(1.1ml/Min)


S-1 20 1075890 5.692

S-2 20 1077184 5.692

S-3 20 1079062 5.692

S-4 20 1078225 5.683

S-5 20 1078195 5.683

S-6 20 1076348 5.675

Average 1077484 5.686

Std, Dev. 1221.96710

%RSD 0.11

Table no. 27: Change in Flow rate -10% (0.9ml)


S-1 20 1319251 6.933

S-2 20 1316586 6.933

S-3 20 1315652 6.933

S-4 20 1314363 6.933

S-5 20 1314406 6.933

S-6 20 1314651 6.933

Average 1315818.17 6.933

Std, Dev. 1890.7949

%RSD 0.14

Table no. 28: The system suitability was evaluated for the respective conditions

Parameter Tailing factor Theoretical

plates

% RSD of

replicates

Limit NMT 2.0 NLT 2000 NMT 2.0 %

Change in wavelength + 5 nm 0.96 4535.24 0.46

Change in wavelength - 5 nm 0.96 4300.54 0.28

Change in column temperature + 5° 0.98 4400.23 0.08

Change in column temperature - 5° 0.95 4451.79 0.09

Change in mobile phase(ACN) + 2 % 0.94 4315.59 0.23

Change in mobile phase(ACN) - 2 % 0.99 4412.26 0.74

Change in pH + 0.2 0.96 4358.01 0.15

Change in pH - 0.2 0.98 4411.23 0.15

Change in flow rate + 10 % 0.97 4368.95 0.11

Change in flow rate - 10 % 0.95 4406.01 0.14

less time consuming. The advantage of the present test

procedures was that it does not require any complicated

mobile phase and it is simple isocratic method. The present method can be confidently be used for rapid and precise

quantization of Rosuvastatin calcium, specially this

procedure can be a major interest in analytical chemistry,

since it offers a distinct quality control in the test procedure of

Assay of Rosuvastatin calcium. The present work shows a

validated, highly sensitive and selective method for

determination of Rosuvastatin calcium in pharmaceutical

dosage forms.

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Highlights of the Report of the Expert Panel on Blood

Cholesterol Levels in; Children and Adolescents,

Pediatrics, 89(1992)495-501.

Source of support: Nil; Conflict of interest: None declared

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